Spectacles for Patients With Down Syndrome
Sponsor
University of Houston (Other)
Overall Status
Completed
CT.gov ID
NCT03367793
Collaborator
(none)
30
1
6
22.3
1.3
Study Details
Study Description
Brief Summary
This study tests the hypothesis that objectively derived spectacle prescriptions based on wavefront aberration measurements of the eyes of individuals with Down syndrome can provide an improvement in visual acuity over that obtained with spectacle prescriptions based on standard clinical prescribing techniques. The objectively derived prescriptions are derived using strategies to optimize retinal image quality as measured by image quality metrics, and thus these prescriptions will be referred to as metric-derived.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Individuals with Down syndrome suffer from significant ocular complications including high levels of lower-order refractive error (sphere and cylinder) and elevated levels of higher-order aberrations. These optical factors likely contribute to the poor acuity observed in this population. Current clinical prescribing practices may under-serve this community, as the cognitive demands of the subjective refraction sequence are difficult for this population and often leave clinicians to prescribe from objective clinical findings that target full correction of sphero-cylindrical refractive error. This prescribing practice can lead to sub-par outcomes given the fact that full lower-order corrections can exacerbate the effects of higher-order aberrations in more aberrated eyes.
For this study, individuals with Down syndrome will be dispensed three pairs of spectacles for 2 months each, in random order: one clinically-derived, and two objectively-derived refractions based upon methods designed to optimize a given metric of retinal image quality which takes into consideration the wavefront aberration measurements of the eye. Both initial and adapted visual acuity in the presence of each correction will be evaluated to determine whether the objectively-derived refractions outperform clinically-derived refractions.
Study Design
Study Type:
Interventional
Actual Enrollment
:
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Identification of Optimum Spectacle Prescriptions for Patients With Down Syndrome
Actual Study Start Date
:
Jan 26, 2018
Actual Primary Completion Date
:
Jun 10, 2019
Actual Study Completion Date
:
Dec 5, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Clinical, then Metric #1, then Metric #2 Each subject will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2. |
Device: Spectacles - Clinically Derived
Prescription spectacle lenses determined by clinically derived techniques. The specific techniques employed for each subject are left up to the masked examiner and are dependent upon the information needed for refraction determination, as well as ability of the participant to cooperate for testing. Measures may include autorefraction obtained pre or post dilation, retinoscopy obtained pre or post dilation, and subjective refraction obtained pre or post dilation.
Other Names:
Device: Spectacles - Metric Technique #1 Derived
Prescription spectacle lenses determined by metric-derived objective technique #1. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis will then be performed using a computer algorithm to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). The refractive correction determined from this analysis will be produced in prescription spectacle lenses and dispensed to the patient as the Intervention: Spectacles - Metric Technique #1 Derived.
Other Names:
Device: Spectacles - Metric Technique #2 Derived
Prescription spectacle lenses determined by metric-derived objective technique #2. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis will then be performed using a computer algorithm to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). The refractive correction determined from this analysis will be produced in prescription spectacle lenses and dispensed to the patient as the Intervention: Spectacles - Metric Technique #2 Derived.
Other Names:
|
| Experimental: Clinical, then Metric #2, then Metric #1 Each subject will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1. |
Device: Spectacles - Clinically Derived
Prescription spectacle lenses determined by clinically derived techniques. The specific techniques employed for each subject are left up to the masked examiner and are dependent upon the information needed for refraction determination, as well as ability of the participant to cooperate for testing. Measures may include autorefraction obtained pre or post dilation, retinoscopy obtained pre or post dilation, and subjective refraction obtained pre or post dilation.
Other Names:
Device: Spectacles - Metric Technique #1 Derived
Prescription spectacle lenses determined by metric-derived objective technique #1. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis will then be performed using a computer algorithm to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). The refractive correction determined from this analysis will be produced in prescription spectacle lenses and dispensed to the patient as the Intervention: Spectacles - Metric Technique #1 Derived.
Other Names:
Device: Spectacles - Metric Technique #2 Derived
Prescription spectacle lenses determined by metric-derived objective technique #2. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis will then be performed using a computer algorithm to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). The refractive correction determined from this analysis will be produced in prescription spectacle lenses and dispensed to the patient as the Intervention: Spectacles - Metric Technique #2 Derived.
Other Names:
|
| Experimental: Metric #1, then Clinical, then Metric #2 Each subject will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived prescription, and lastly the metric-derived #2 prescription. |
Device: Spectacles - Clinically Derived
Prescription spectacle lenses determined by clinically derived techniques. The specific techniques employed for each subject are left up to the masked examiner and are dependent upon the information needed for refraction determination, as well as ability of the participant to cooperate for testing. Measures may include autorefraction obtained pre or post dilation, retinoscopy obtained pre or post dilation, and subjective refraction obtained pre or post dilation.
Other Names:
Device: Spectacles - Metric Technique #1 Derived
Prescription spectacle lenses determined by metric-derived objective technique #1. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis will then be performed using a computer algorithm to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). The refractive correction determined from this analysis will be produced in prescription spectacle lenses and dispensed to the patient as the Intervention: Spectacles - Metric Technique #1 Derived.
Other Names:
Device: Spectacles - Metric Technique #2 Derived
Prescription spectacle lenses determined by metric-derived objective technique #2. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis will then be performed using a computer algorithm to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). The refractive correction determined from this analysis will be produced in prescription spectacle lenses and dispensed to the patient as the Intervention: Spectacles - Metric Technique #2 Derived.
Other Names:
|
| Experimental: Metric #2, then Clinical, then Metric #1 Each subject will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived prescription, and lastly the metric-derived #1 prescription. |
Device: Spectacles - Clinically Derived
Prescription spectacle lenses determined by clinically derived techniques. The specific techniques employed for each subject are left up to the masked examiner and are dependent upon the information needed for refraction determination, as well as ability of the participant to cooperate for testing. Measures may include autorefraction obtained pre or post dilation, retinoscopy obtained pre or post dilation, and subjective refraction obtained pre or post dilation.
Other Names:
Device: Spectacles - Metric Technique #1 Derived
Prescription spectacle lenses determined by metric-derived objective technique #1. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis will then be performed using a computer algorithm to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). The refractive correction determined from this analysis will be produced in prescription spectacle lenses and dispensed to the patient as the Intervention: Spectacles - Metric Technique #1 Derived.
Other Names:
Device: Spectacles - Metric Technique #2 Derived
Prescription spectacle lenses determined by metric-derived objective technique #2. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis will then be performed using a computer algorithm to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). The refractive correction determined from this analysis will be produced in prescription spectacle lenses and dispensed to the patient as the Intervention: Spectacles - Metric Technique #2 Derived.
Other Names:
|
| Experimental: Metric #1, then Metric #2, then Clinical Each subject will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2 prescription, and lastly the clinically derived prescription. |
Device: Spectacles - Clinically Derived
Prescription spectacle lenses determined by clinically derived techniques. The specific techniques employed for each subject are left up to the masked examiner and are dependent upon the information needed for refraction determination, as well as ability of the participant to cooperate for testing. Measures may include autorefraction obtained pre or post dilation, retinoscopy obtained pre or post dilation, and subjective refraction obtained pre or post dilation.
Other Names:
Device: Spectacles - Metric Technique #1 Derived
Prescription spectacle lenses determined by metric-derived objective technique #1. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis will then be performed using a computer algorithm to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). The refractive correction determined from this analysis will be produced in prescription spectacle lenses and dispensed to the patient as the Intervention: Spectacles - Metric Technique #1 Derived.
Other Names:
Device: Spectacles - Metric Technique #2 Derived
Prescription spectacle lenses determined by metric-derived objective technique #2. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis will then be performed using a computer algorithm to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). The refractive correction determined from this analysis will be produced in prescription spectacle lenses and dispensed to the patient as the Intervention: Spectacles - Metric Technique #2 Derived.
Other Names:
|
| Experimental: Metric #2, then Metric #1, then Clinical Each subject will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1 prescription, and lastly the clinically derived prescription. |
Device: Spectacles - Clinically Derived
Prescription spectacle lenses determined by clinically derived techniques. The specific techniques employed for each subject are left up to the masked examiner and are dependent upon the information needed for refraction determination, as well as ability of the participant to cooperate for testing. Measures may include autorefraction obtained pre or post dilation, retinoscopy obtained pre or post dilation, and subjective refraction obtained pre or post dilation.
Other Names:
Device: Spectacles - Metric Technique #1 Derived
Prescription spectacle lenses determined by metric-derived objective technique #1. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis will then be performed using a computer algorithm to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). The refractive correction determined from this analysis will be produced in prescription spectacle lenses and dispensed to the patient as the Intervention: Spectacles - Metric Technique #1 Derived.
Other Names:
Device: Spectacles - Metric Technique #2 Derived
Prescription spectacle lenses determined by metric-derived objective technique #2. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis will then be performed using a computer algorithm to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). The refractive correction determined from this analysis will be produced in prescription spectacle lenses and dispensed to the patient as the Intervention: Spectacles - Metric Technique #2 Derived.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Adapted Visual Acuity [two months]
Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters.
Secondary Outcome Measures
- Initial Visual Acuity [1 day]
Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters.
- Spectacle Wear Time [two months]
Total wear time of each pair of spectacles as measured objectively by a temperature sensor data logger mounted to the spectacle temple.
- Spectacle Assessment Survey Question 1 [two months]
Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'Do you like wearing this pair of glasses?' Responses were coded 1 through 5 with 5 = large smile.
- Spectacle Assessment Survey Question 2 [two months]
Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'How well do you see with this pair of glasses when looking far away?' Responses were coded 1 through 5 with 5 = large smile.
- Spectacle Assessment Survey Question 3 [two months]
Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'How well do you see with this pair of glasses when looking up close?' Responses were coded 1 through 5 with 5 = large smile.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Diagnosis of Down syndrome
Exclusion Criteria:
-
Nystagmus (Involuntary beating movement of the eyes)
-
Visually significant media opacities (e.g. cataracts or corneal scars)
-
Strabismic amblyopia (reduced vision in one eye related to a constant eye-turn)
-
Anisometropic amblyopia (reduced vision in one eye related to a long-standing uncompensated difference in prescription between the two eyes)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Houston | Houston | Texas | United States | 77204 |
Sponsors and Collaborators
- University of Houston
Investigators
- Principal Investigator: Heather A Anderson, OD, PhD, University of Houston
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Heather A. Anderson,
Associate Professor,
University of Houston
ClinicalTrials.gov Identifier:
NCT03367793
Other Study ID Numbers:
- EY024590
First Posted:
Dec 11, 2017
Last Update Posted:
Oct 25, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical |
|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). |
| Period Title: Initial Acuity at Dispense Visit (10min) | ||||||
| STARTED | 5 | 5 | 5 | 5 | 5 | 5 |
| COMPLETED | 5 | 5 | 5 | 5 | 5 | 5 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
| Period Title: Initial Acuity at Dispense Visit (10min) | ||||||
| STARTED | 5 | 5 | 5 | 5 | 5 | 5 |
| COMPLETED | 5 | 5 | 5 | 5 | 5 | 5 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
| Period Title: Initial Acuity at Dispense Visit (10min) | ||||||
| STARTED | 5 | 5 | 5 | 5 | 5 | 5 |
| COMPLETED | 5 | 5 | 4 | 5 | 5 | 5 |
| NOT COMPLETED | 0 | 0 | 1 | 0 | 0 | 0 |
| Period Title: Initial Acuity at Dispense Visit (10min) | ||||||
| STARTED | 5 | 5 | 5 | 5 | 5 | 5 |
| COMPLETED | 5 | 5 | 5 | 5 | 5 | 5 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Total of all reporting groups |
| Overall Participants | 5 | 5 | 5 | 5 | 5 | 5 | 30 |
| Age (years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [years] |
32
(9)
|
30
(13)
|
34
(9)
|
28
(12)
|
24
(4)
|
28
(10)
|
29
(10)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
3
60%
|
1
20%
|
3
60%
|
1
20%
|
3
60%
|
4
80%
|
15
50%
|
| Male |
2
40%
|
4
80%
|
2
40%
|
4
80%
|
2
40%
|
1
20%
|
15
50%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||||
| Hispanic or Latino |
1
20%
|
1
20%
|
1
20%
|
1
20%
|
1
20%
|
2
40%
|
7
23.3%
|
| Not Hispanic or Latino |
4
80%
|
4
80%
|
4
80%
|
4
80%
|
4
80%
|
3
60%
|
23
76.7%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
1
20%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
3.3%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
40%
|
0
0%
|
0
0%
|
1
20%
|
0
0%
|
1
20%
|
4
13.3%
|
| White |
3
60%
|
3
60%
|
5
100%
|
3
60%
|
5
100%
|
4
80%
|
23
76.7%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
1
20%
|
0
0%
|
0
0%
|
1
3.3%
|
| Unknown or Not Reported |
0
0%
|
1
20%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
3.3%
|
| Region of Enrollment (participants) [Number] | |||||||
| United States |
5
100%
|
5
100%
|
5
100%
|
5
100%
|
5
100%
|
5
100%
|
30
100%
|
| Adaptive Behavior Standard Score (Standard Score) [Median (Full Range) ] | |||||||
| Median (Full Range) [Standard Score] |
74
|
73
|
59
|
60
|
57
|
59
|
60
|
| Binocular Distance Visual Acuity (logMAR) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [logMAR] |
0.30
(.10)
|
0.48
(0.29)
|
0.40
(0.13)
|
0.38
(0.15)
|
0.46
(0.16)
|
0.30
(0.14)
|
0.39
(0.17)
|
| Number presenting with spectacles (Count of Participants) | |||||||
| Count of Participants [Participants] |
4
80%
|
4
80%
|
3
60%
|
4
80%
|
2
40%
|
4
80%
|
21
70%
|
| Refractive Error Classification (Number of Eyes) [Number] | |||||||
| Myopia |
5
|
1
|
4
|
1
|
8
|
4
|
23
|
| Hyperopia |
4
|
6
|
3
|
4
|
1
|
3
|
21
|
| Mixed Astigmatism |
1
|
3
|
3
|
5
|
0
|
3
|
15
|
| Emmetropia |
0
|
0
|
0
|
0
|
1
|
0
|
1
|
| Autorefraction Spherical Equivalent OD (Diopters) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [Diopters] |
-1.68
(4.53)
|
1.93
(3.07)
|
-3.73
(7.33)
|
0.98
(1.27)
|
-1.75
(4.37)
|
-5.23
(4.75)
|
-1.58
(4.88)
|
| Autorefraction Spherical Equivalent OS (Diopters) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [Diopters] |
-2.03
(5.91)
|
1.95
(2.52)
|
-2.68
(6.81)
|
-0.05
(2.43)
|
-1.58
(4.55)
|
-3.53
(3.73)
|
-1.32
(4.59)
|
| Autorefraction Cylinder OD (Diopters) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [Diopters] |
-1.45
(0.67)
|
-3.65
(1.43)
|
-2.65
(2.91)
|
-2.25
(1.08)
|
-1.50
(0.68)
|
-1.35
(0.68)
|
-2.14
(1.58)
|
| Autorefraction Cylinder OS (Diopters) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [Diopters] |
-1.15
(0.68)
|
-3.60
(1.32)
|
-1.55
(1.81)
|
-2.10
(0.42)
|
-1.95
(1.45)
|
-2.05
(0.37)
|
-2.07
(1.30)
|
Outcome Measures
| Title | Adapted Visual Acuity |
|---|---|
| Description | Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters. |
| Time Frame | two months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Spectacles from the clinical treatment method were not dispensed to one participant in the Metric #1, then Clinical, then Metric #2 group due to failure of the safety criteria required for dispense. This spectacle prescription resulted in visual acuity worse than 7 letters from the participant's presenting acuity to the study. |
| Arm/Group Title | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical |
|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). |
| Measure Participants | 5 | 5 | 5 | 5 | 5 | 5 |
| Period 2 Treatment 1 Dispense to 2 Months Wear |
0.256
(0.110)
|
0.440
(0.240)
|
0.356
(0.149)
|
0.284
(0.089)
|
0.300
(0.163)
|
0.364
(0.048)
|
| Period 3 Treatment 2 Dispense to 2 Months Wear |
0.272
(0.135)
|
0.412
(0.215)
|
0.370
(0.093)
|
0.316
(0.157)
|
0.256
(0.344)
|
0.316
(0.091)
|
| Period 4 Treatment 3 Dispense to 2 Months Wear |
0.288
(0.100)
|
0.424
(00.238)
|
0.320
(0.117)
|
0.276
(0.140)
|
0.216
(0.119)
|
0.372
(0.091)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Clinical, Then Metric #1, Then Metric #2, Clinical, Then Metric #2, Then Metric #1, Metric #1, Then Clinical, Then Metric #2, Metric #2, Then Clinical, Then Metric #1, Metric #1, Then Metric #2, Then Clinical, Metric #2, Then Metric #1, Then Clinical |
|---|---|---|
| Comments | It was calculated that 29 participants randomized in a 3x3 within-subject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2-sided f-test (alpha = 0.05) of the overall treatment effect based on a statistical simulation, simulating the repeated measures design. Assumptions included ICC of 0.3. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.341 |
| Comments | The threshold for statistical significance was 0.05. | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | f statistic |
| Estimated Value | 1.10 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Clinical, Then Metric #1, Then Metric #2, Clinical, Then Metric #2, Then Metric #1, Metric #1, Then Clinical, Then Metric #2, Metric #2, Then Clinical, Then Metric #1, Metric #1, Then Metric #2, Then Clinical, Metric #2, Then Metric #1, Then Clinical |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | least square means |
| Estimated Value | 0.31 | |
| Confidence Interval |
(2-Sided) 95% 0.26 to 0.36 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Additional model based estimates for 2-month estimated least square means in binocular visual acuity (logMAR) for PFST. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Clinical, Then Metric #1, Then Metric #2, Clinical, Then Metric #2, Then Metric #1, Metric #1, Then Clinical, Then Metric #2, Metric #2, Then Clinical, Then Metric #1, Metric #1, Then Metric #2, Then Clinical, Metric #2, Then Metric #1, Then Clinical |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | least square means |
| Estimated Value | 0.33 | |
| Confidence Interval |
(2-Sided) 95% 0.27 to 0.38 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Additional model based estimates for 2-month estimated least square means in binocular visual acuity (logMAR) for VSX. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Clinical, Then Metric #1, Then Metric #2, Clinical, Then Metric #2, Then Metric #1, Metric #1, Then Clinical, Then Metric #2, Metric #2, Then Clinical, Then Metric #1, Metric #1, Then Metric #2, Then Clinical, Metric #2, Then Metric #1, Then Clinical |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | least square means |
| Estimated Value | 0.34 | |
| Confidence Interval |
(2-Sided) 95% 0.28 to 0.39 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Additional model based estimates for 2-month estimated least square means in binocular visual acuity (logMAR) for Clinical Refraction. | |
| Title | Initial Visual Acuity |
|---|---|
| Description | Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters. |
| Time Frame | 1 day |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical |
|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). |
| Measure Participants | 5 | 5 | 5 | 5 | 5 | 5 |
| Treatment 1 Initial Dispense |
0.28
(0.14)
|
0.43
(0.25)
|
0.34
(0.22)
|
0.28
(0.13)
|
0.29
(0.35)
|
0.33
(0.09)
|
| Treatment 2 Initial Dispense |
0.25
(0.08)
|
0.43
(0.25)
|
0.36
(0.18)
|
0.30
(0.22)
|
0.30
(0.15)
|
0.34
(0.07)
|
| Treatment 3 Initial Dispense |
0.31
(0.40)
|
0.44
(0.24)
|
0.40
(0.16)
|
0.32
(0.18)
|
0.28
(0.14)
|
0.40
(0.05)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Clinical, Then Metric #1, Then Metric #2, Clinical, Then Metric #2, Then Metric #1, Metric #1, Then Clinical, Then Metric #2, Metric #2, Then Clinical, Then Metric #1, Metric #1, Then Metric #2, Then Clinical, Metric #2, Then Metric #1, Then Clinical |
|---|---|---|
| Comments | It was calculated that 29 participants randomized in a 3x3 within-subject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2-sided f-test (alpha = 0.05) of the overall treatment effect based on a statistical simulation, simulating the repeated measures design. Assumptions included ICC of 0.3. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.410 |
| Comments | The threshold for statistical significance was 0.05. | |
| Method | f test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | f statistic |
| Estimated Value | 0.93 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Clinical, Then Metric #1, Then Metric #2, Clinical, Then Metric #2, Then Metric #1, Metric #1, Then Clinical, Then Metric #2, Metric #2, Then Clinical, Then Metric #1, Metric #1, Then Metric #2, Then Clinical, Metric #2, Then Metric #1, Then Clinical |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | least square means |
| Estimated Value | 0.35 | |
| Confidence Interval |
(2-Sided) 95% 0.28 to 0.41 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Additional model based estimates for initial visit estimated least square means in binocular visual acuity (logMAR) for PFST. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Clinical, Then Metric #1, Then Metric #2, Clinical, Then Metric #2, Then Metric #1, Metric #1, Then Clinical, Then Metric #2, Metric #2, Then Clinical, Then Metric #1, Metric #1, Then Metric #2, Then Clinical, Metric #2, Then Metric #1, Then Clinical |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | least square means |
| Estimated Value | 0.33 | |
| Confidence Interval |
(2-Sided) 95% 0.26 to 0.39 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Additional model based estimates for initial visit estimated least square means in binocular visual acuity (logMAR) for VSX. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Clinical, Then Metric #1, Then Metric #2, Clinical, Then Metric #2, Then Metric #1, Metric #1, Then Clinical, Then Metric #2, Metric #2, Then Clinical, Then Metric #1, Metric #1, Then Metric #2, Then Clinical, Metric #2, Then Metric #1, Then Clinical |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | least square means |
| Estimated Value | 0.34 | |
| Confidence Interval |
(2-Sided) 95% 0.28 to 0.41 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Additional model based estimates for initial visit estimated least square means in binocular visual acuity (logMAR) for Clinical Refraction. | |
| Title | Spectacle Wear Time |
|---|---|
| Description | Total wear time of each pair of spectacles as measured objectively by a temperature sensor data logger mounted to the spectacle temple. |
| Time Frame | two months |
Outcome Measure Data
| Analysis Population Description |
|---|
| For Period 3, one participant in group Metric #1, then Clinical, then Metric #2 did not receive the Clinical spectacle treatment because it failed the safety criteria for dispense. The clinical treatment for that participant reduced visual acuity greater than 7 letters from presenting acuity. |
| Arm/Group Title | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical |
|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). |
| Measure Participants | 5 | 5 | 5 | 5 | 5 | 5 |
| Period 2 Treatment 1 Dispense to 2 Months Wear |
11.93
(4.95)
|
13.15
(3.96)
|
10.48
(4.08)
|
9.81
(4.32)
|
8.40
(4.29)
|
11.62
(2.55)
|
| Period 3 Treatment 2 Dispense to 2 Months Wear |
9.50
(5.50)
|
12.68
(5.82)
|
12.31
(4.74)
|
9.67
(4.85)
|
9.26
(4.17)
|
11.25
(2.96)
|
| Period 4 Treatment 3 Dispense to 2 Months Wear |
11.61
(6.05)
|
13.32
(4.53)
|
11.95
(4.18)
|
9.47
(5.12)
|
9.54
(4.34)
|
11.31
(3.06)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Clinical, Then Metric #1, Then Metric #2, Clinical, Then Metric #2, Then Metric #1, Metric #1, Then Clinical, Then Metric #2, Metric #2, Then Clinical, Then Metric #1, Metric #1, Then Metric #2, Then Clinical, Metric #2, Then Metric #1, Then Clinical |
|---|---|---|
| Comments | It was calculated that 29 participants randomized in a 3x3 within-subject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2-sided f-test (alpha = 0.05) of the overall treatment effect based on a statistical simulation, simulating the repeated measures design. Assumptions included ICC of 0.3. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.351 |
| Comments | The threshold for statistical significance was alpha=0.05. | |
| Method | f test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | f statistic |
| Estimated Value | 1.09 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Clinical, Then Metric #1, Then Metric #2, Clinical, Then Metric #2, Then Metric #1, Metric #1, Then Clinical, Then Metric #2, Metric #2, Then Clinical, Then Metric #1, Metric #1, Then Metric #2, Then Clinical, Metric #2, Then Metric #1, Then Clinical |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | least square means |
| Estimated Value | 11.0 | |
| Confidence Interval |
(2-Sided) 95% 9.3 to 12.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Additional model based estimates for two-month wear time estimated least square means in spectacle wear-time (Hours) for PFST. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Clinical, Then Metric #1, Then Metric #2, Clinical, Then Metric #2, Then Metric #1, Metric #1, Then Clinical, Then Metric #2, Metric #2, Then Clinical, Then Metric #1, Metric #1, Then Metric #2, Then Clinical, Metric #2, Then Metric #1, Then Clinical |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | least square means |
| Estimated Value | 10.9 | |
| Confidence Interval |
(2-Sided) 95% 9.2 to 12.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Additional model based estimates for two-month wear time estimated least square means in spectacle wear-time (Hours) for VSX. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Clinical, Then Metric #1, Then Metric #2, Clinical, Then Metric #2, Then Metric #1, Metric #1, Then Clinical, Then Metric #2, Metric #2, Then Clinical, Then Metric #1, Metric #1, Then Metric #2, Then Clinical, Metric #2, Then Metric #1, Then Clinical |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | least square means |
| Estimated Value | 11.2 | |
| Confidence Interval |
(2-Sided) 95% 9.5 to 12.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Additional model based estimates for two-month wear time estimated least square means in spectacle wear-time (Hours) for Clinical Refraction. | |
| Title | Spectacle Assessment Survey Question 1 |
|---|---|
| Description | Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'Do you like wearing this pair of glasses?' Responses were coded 1 through 5 with 5 = large smile. |
| Time Frame | two months |
Outcome Measure Data
| Analysis Population Description |
|---|
| A single participant from group 'Metric #1, then Clinical, then Metric #2' was not dispensed the clinical treatment due to the treatment failing one of the safety criteria for dispense. |
| Arm/Group Title | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical |
|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). |
| Measure Participants | 5 | 5 | 5 | 5 | 5 | 5 |
| Period 2 Treatment 1 Dispense to 2 Months Wear |
5
|
5
|
5
|
5
|
5
|
5
|
| Period 3 Treatment 2 Dispense to 2 Months Wear |
5
|
5
|
5
|
5
|
5
|
4
|
| Period 4 Treatment 3 Dispense to 2 Months Wear |
5
|
5
|
5
|
5
|
5
|
4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Clinical, Then Metric #1, Then Metric #2, Clinical, Then Metric #2, Then Metric #1, Metric #1, Then Clinical, Then Metric #2, Metric #2, Then Clinical, Then Metric #1, Metric #1, Then Metric #2, Then Clinical, Metric #2, Then Metric #1, Then Clinical |
|---|---|---|
| Comments | It was calculated that a sample size of n=28 yields 82% power to detect a difference of 0.4 in proportion of satisfaction (binary outcome of scores of '4' or '5' versus '1 to 3') in comparing two metrics using a two sided McNemar's test (alpha = 0.025 to account for pairwise testing). | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.562 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | f statistic |
| Estimated Value | 0.58 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Clinical, Then Metric #1, Then Metric #2, Clinical, Then Metric #2, Then Metric #1, Metric #1, Then Clinical, Then Metric #2, Metric #2, Then Clinical, Then Metric #1, Metric #1, Then Metric #2, Then Clinical, Metric #2, Then Metric #1, Then Clinical |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | proportion |
| Estimated Value | 0.967 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 1 for PFST. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Clinical, Then Metric #1, Then Metric #2, Clinical, Then Metric #2, Then Metric #1, Metric #1, Then Clinical, Then Metric #2, Metric #2, Then Clinical, Then Metric #1, Metric #1, Then Metric #2, Then Clinical, Metric #2, Then Metric #1, Then Clinical |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | proportion |
| Estimated Value | 0.933 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 1 for VSX. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Clinical, Then Metric #1, Then Metric #2, Clinical, Then Metric #2, Then Metric #1, Metric #1, Then Clinical, Then Metric #2, Metric #2, Then Clinical, Then Metric #1, Metric #1, Then Metric #2, Then Clinical, Metric #2, Then Metric #1, Then Clinical |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | proportion |
| Estimated Value | 0.897 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 1 for Clinical Refraction. | |
| Title | Spectacle Assessment Survey Question 2 |
|---|---|
| Description | Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'How well do you see with this pair of glasses when looking far away?' Responses were coded 1 through 5 with 5 = large smile. |
| Time Frame | two months |
Outcome Measure Data
| Analysis Population Description |
|---|
| A single participant from group 'Metric #1, then Clinical, then Metric #2' was not dispensed the clinical treatment due to the treatment failing one of the safety criteria for dispense. |
| Arm/Group Title | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical |
|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). |
| Measure Participants | 5 | 5 | 5 | 5 | 5 | 5 |
| Period 2 Treatment 1 Dispense to 2 Months Wear |
5
|
5
|
5
|
5
|
5
|
5
|
| Period 3 Treatment 2 Dispense to 2 Months Wear |
5
|
5
|
4.5
|
5
|
5
|
4
|
| Period 4 Treatment 3 Dispense to 2 Months Wear |
5
|
5
|
5
|
5
|
5
|
5
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Clinical, Then Metric #1, Then Metric #2, Clinical, Then Metric #2, Then Metric #1, Metric #1, Then Clinical, Then Metric #2, Metric #2, Then Clinical, Then Metric #1, Metric #1, Then Metric #2, Then Clinical, Metric #2, Then Metric #1, Then Clinical |
|---|---|---|
| Comments | It was calculated that a sample size of n=28 yields 82% power to detect a difference of 0.4 in proportion of satisfaction (binary outcome of scores of '4' or '5' versus '1 to 3') in comparing two metrics using a two sided McNemar's test (alpha = 0.025 to account for pairwise testing). | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.99 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Clinical, Then Metric #1, Then Metric #2, Clinical, Then Metric #2, Then Metric #1, Metric #1, Then Clinical, Then Metric #2, Metric #2, Then Clinical, Then Metric #1, Metric #1, Then Metric #2, Then Clinical, Metric #2, Then Metric #1, Then Clinical |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | proportion |
| Estimated Value | 0.967 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Additional estimates of proportion of 2-month satisfactory responses (binary) for 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 2 for PFST. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Clinical, Then Metric #1, Then Metric #2, Clinical, Then Metric #2, Then Metric #1, Metric #1, Then Clinical, Then Metric #2, Metric #2, Then Clinical, Then Metric #1, Metric #1, Then Metric #2, Then Clinical, Metric #2, Then Metric #1, Then Clinical |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | proportion |
| Estimated Value | 0.967 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 2 for VSX. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Clinical, Then Metric #1, Then Metric #2, Clinical, Then Metric #2, Then Metric #1, Metric #1, Then Clinical, Then Metric #2, Metric #2, Then Clinical, Then Metric #1, Metric #1, Then Metric #2, Then Clinical, Metric #2, Then Metric #1, Then Clinical |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | proportion |
| Estimated Value | 0.966 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 2 for Clinical Refraction. | |
| Title | Spectacle Assessment Survey Question 3 |
|---|---|
| Description | Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'How well do you see with this pair of glasses when looking up close?' Responses were coded 1 through 5 with 5 = large smile. |
| Time Frame | two months |
Outcome Measure Data
| Analysis Population Description |
|---|
| A single participant from group 'Metric #1, then Clinical, then Metric #2' was not dispensed the clinical treatment due to the treatment failing one of the safety criteria for dispense. |
| Arm/Group Title | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical |
|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived. Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). |
| Measure Participants | 5 | 5 | 5 | 5 | 5 | 5 |
| Period 2 Treatment 1 Dispense to 2 Months Wear |
5
|
5
|
5
|
5
|
5
|
5
|
| Period 3 Treatment 2 Dispense to 2 Months Wear |
5
|
5
|
5
|
5
|
5
|
5
|
| Period 4 Treatment 3 Dispense to 2 Months Wear |
5
|
5
|
5
|
5
|
5
|
5
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Clinical, Then Metric #1, Then Metric #2, Clinical, Then Metric #2, Then Metric #1, Metric #1, Then Clinical, Then Metric #2, Metric #2, Then Clinical, Then Metric #1, Metric #1, Then Metric #2, Then Clinical, Metric #2, Then Metric #1, Then Clinical |
|---|---|---|
| Comments | It was calculated that a sample size of n=28 yields 82% power to detect a difference of 0.4 in proportion of satisfaction (binary outcome of scores of '4' or '5' versus '1 to 3') in comparing two metrics using a two sided McNemar's test (alpha = 0.025 to account for pairwise testing). | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | >0.99 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Clinical, Then Metric #1, Then Metric #2, Clinical, Then Metric #2, Then Metric #1, Metric #1, Then Clinical, Then Metric #2, Metric #2, Then Clinical, Then Metric #1, Metric #1, Then Metric #2, Then Clinical, Metric #2, Then Metric #1, Then Clinical |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | proportion |
| Estimated Value | 0.967 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 3 for PFST. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Clinical, Then Metric #1, Then Metric #2, Clinical, Then Metric #2, Then Metric #1, Metric #1, Then Clinical, Then Metric #2, Metric #2, Then Clinical, Then Metric #1, Metric #1, Then Metric #2, Then Clinical, Metric #2, Then Metric #1, Then Clinical |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | proportion |
| Estimated Value | 0.967 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 3 for VSX. | |
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Clinical, Then Metric #1, Then Metric #2, Clinical, Then Metric #2, Then Metric #1, Metric #1, Then Clinical, Then Metric #2, Metric #2, Then Clinical, Then Metric #1, Metric #1, Then Metric #2, Then Clinical, Metric #2, Then Metric #1, Then Clinical |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | proportion |
| Estimated Value | 0.966 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 3 for Clinical Refraction. | |
Adverse Events
| Time Frame | Adverse event data were collected from the time of dispense of the first treatment through follow up of the final dispensed treatment (6 months total). | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Parents/guardians of participants were contacted by phone one day and one week after each new treatment was dispensed to inquire whether participants were having any difficulty with the glasses. At every visit, participants and their family member were asked if there had been any medical or medication changes since the last visit and if they had any concerns about the spectacles or any new ocular or visual complaints. Reports of glasses needing a fit adjustment were not considered AEs. | |||||
| Arm/Group Title | Clinical | Metric #1 | Metric #2 | |||
| Arm/Group Description | Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation. | Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). | Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). | |||
All Cause Mortality |
||||||
| Clinical | Metric #1 | Metric #2 | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/29 (0%) | 0/30 (0%) | 0/30 (0%) | |||
Serious Adverse Events |
||||||
| Clinical | Metric #1 | Metric #2 | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/29 (0%) | 0/30 (0%) | 0/30 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Clinical | Metric #1 | Metric #2 | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/29 (24.1%) | 5/30 (16.7%) | 4/30 (13.3%) | |||
| Eye disorders | ||||||
| Vision complaint related to comparison with earlier randomized treatment or habitual spectacles | 7/29 (24.1%) | 7 | 1/30 (3.3%) | 1 | 2/30 (6.7%) | 2 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Upper Respiratory Symptoms | 0/29 (0%) | 0 | 4/30 (13.3%) | 5 | 2/30 (6.7%) | 3 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Heather Anderson, Study PI |
|---|---|
| Organization | Ohio State University College of Optometry |
| Phone | 614-247-5825 |
| anderson.3881@osu.edu |
Responsible Party:
Heather A. Anderson,
Associate Professor,
University of Houston
ClinicalTrials.gov Identifier:
NCT03367793
Other Study ID Numbers:
- EY024590
First Posted:
Dec 11, 2017
Last Update Posted:
Oct 25, 2021
Last Verified:
Sep 1, 2021