Spectacles for Patients With Down Syndrome
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 metricderived.
Condition or Disease  Intervention/Treatment  Phase 


N/A 
Detailed Description
Individuals with Down syndrome suffer from significant ocular complications including high levels of lowerorder refractive error (sphere and cylinder) and elevated levels of higherorder aberrations. These optical factors likely contribute to the poor acuity observed in this population. Current clinical prescribing practices may underserve 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 spherocylindrical refractive error. This prescribing practice can lead to subpar outcomes given the fact that full lowerorder corrections can exacerbate the effects of higherorder 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 clinicallyderived, and two objectivelyderived 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 objectivelyderived refractions outperform clinicallyderived refractions.
Study Design
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 metricderived #1, and lastly the metricderived #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 metricderived objective technique #1. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer postdilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived objective technique #2. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer postdilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2, and lastly the metricderived #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 metricderived objective technique #1. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer postdilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived objective technique #2. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer postdilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #1 prescription first, followed by the clinically derived prescription, and lastly the metricderived #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 metricderived objective technique #1. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer postdilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived objective technique #2. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer postdilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2 prescription first, followed by the clinically derived prescription, and lastly the metricderived #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 metricderived objective technique #1. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer postdilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived objective technique #2. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer postdilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #1 prescription first, followed by the metricderived #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 metricderived objective technique #1. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer postdilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived objective technique #2. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer postdilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2 prescription first, followed by the metricderived #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 metricderived objective technique #1. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer postdilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived objective technique #2. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer postdilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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
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 eyeturn)

Anisometropic amblyopia (reduced vision in one eye related to a longstanding 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 (FullText)
More Information
Publications
None provided. EY024590
Study Results
Participant Flow
Recruitment Details  

Preassignment 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 metricderived #1, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #1 prescription first, followed by the clinically derived, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2 prescription first, followed by the clinically derived, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #1 prescription first, followed by the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2 prescription first, followed by the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #1, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #1 prescription first, followed by the clinically derived, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2 prescription first, followed by the clinically derived, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #1 prescription first, followed by the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2 prescription first, followed by the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #1, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #1 prescription first, followed by the clinically derived, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2 prescription first, followed by the clinically derived, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #1 prescription first, followed by the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2 prescription first, followed by the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 withinsubject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2sided ftest (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  pValue  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 
(2Sided) % 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  pValue  
Comments  
Method  
Comments  
Method of Estimation  Estimation Parameter  least square means 
Estimated Value  0.31  
Confidence Interval 
(2Sided) 95% 0.26 to 0.36 

Parameter Dispersion 
Type: Value: 

Estimation Comments  Additional model based estimates for 2month 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  pValue  
Comments  
Method  
Comments  
Method of Estimation  Estimation Parameter  least square means 
Estimated Value  0.33  
Confidence Interval 
(2Sided) 95% 0.27 to 0.38 

Parameter Dispersion 
Type: Value: 

Estimation Comments  Additional model based estimates for 2month 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  pValue  
Comments  
Method  
Comments  
Method of Estimation  Estimation Parameter  least square means 
Estimated Value  0.34  
Confidence Interval 
(2Sided) 95% 0.28 to 0.39 

Parameter Dispersion 
Type: Value: 

Estimation Comments  Additional model based estimates for 2month 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 metricderived #1, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #1 prescription first, followed by the clinically derived, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2 prescription first, followed by the clinically derived, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #1 prescription first, followed by the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2 prescription first, followed by the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 withinsubject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2sided ftest (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  pValue  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 
(2Sided) % 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  pValue  
Comments  
Method  
Comments  
Method of Estimation  Estimation Parameter  least square means 
Estimated Value  0.35  
Confidence Interval 
(2Sided) 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  pValue  
Comments  
Method  
Comments  
Method of Estimation  Estimation Parameter  least square means 
Estimated Value  0.33  
Confidence Interval 
(2Sided) 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  pValue  
Comments  
Method  
Comments  
Method of Estimation  Estimation Parameter  least square means 
Estimated Value  0.34  
Confidence Interval 
(2Sided) 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 metricderived #1, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #1 prescription first, followed by the clinically derived, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2 prescription first, followed by the clinically derived, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #1 prescription first, followed by the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2 prescription first, followed by the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 withinsubject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2sided ftest (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  pValue  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 
(2Sided) % 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  pValue  
Comments  
Method  
Comments  
Method of Estimation  Estimation Parameter  least square means 
Estimated Value  11.0  
Confidence Interval 
(2Sided) 95% 9.3 to 12.7 

Parameter Dispersion 
Type: Value: 

Estimation Comments  Additional model based estimates for twomonth wear time estimated least square means in spectacle weartime (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  pValue  
Comments  
Method  
Comments  
Method of Estimation  Estimation Parameter  least square means 
Estimated Value  10.9  
Confidence Interval 
(2Sided) 95% 9.2 to 12.6 

Parameter Dispersion 
Type: Value: 

Estimation Comments  Additional model based estimates for twomonth wear time estimated least square means in spectacle weartime (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  pValue  
Comments  
Method  
Comments  
Method of Estimation  Estimation Parameter  least square means 
Estimated Value  11.2  
Confidence Interval 
(2Sided) 95% 9.5 to 12.9 

Parameter Dispersion 
Type: Value: 

Estimation Comments  Additional model based estimates for twomonth wear time estimated least square means in spectacle weartime (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 metricderived #1, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #1 prescription first, followed by the clinically derived, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2 prescription first, followed by the clinically derived, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #1 prescription first, followed by the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2 prescription first, followed by the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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  pValue  0.562 
Comments  
Method  Mixed Models Analysis  
Comments  
Method of Estimation  Estimation Parameter  f statistic 
Estimated Value  0.58  
Confidence Interval 
(2Sided) % 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  pValue  
Comments  
Method  
Comments  
Method of Estimation  Estimation Parameter  proportion 
Estimated Value  0.967  
Confidence Interval 
(2Sided) % to 

Parameter Dispersion 
Type: Value: 

Estimation Comments  Additional estimates of proportion of 2month 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  pValue  
Comments  
Method  
Comments  
Method of Estimation  Estimation Parameter  proportion 
Estimated Value  0.933  
Confidence Interval 
(2Sided) % to 

Parameter Dispersion 
Type: Value: 

Estimation Comments  Additional estimates of proportion of 2month 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  pValue  
Comments  
Method  
Comments  
Method of Estimation  Estimation Parameter  proportion 
Estimated Value  0.897  
Confidence Interval 
(2Sided) % to 

Parameter Dispersion 
Type: Value: 

Estimation Comments  Additional estimates of proportion of 2month 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 metricderived #1, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #1 prescription first, followed by the clinically derived, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2 prescription first, followed by the clinically derived, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #1 prescription first, followed by the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2 prescription first, followed by the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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  pValue  >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  pValue  
Comments  
Method  
Comments  
Method of Estimation  Estimation Parameter  proportion 
Estimated Value  0.967  
Confidence Interval 
(2Sided) % to 

Parameter Dispersion 
Type: Value: 

Estimation Comments  Additional estimates of proportion of 2month satisfactory responses (binary) for 2month 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  pValue  
Comments  
Method  
Comments  
Method of Estimation  Estimation Parameter  proportion 
Estimated Value  0.967  
Confidence Interval 
(2Sided) % to 

Parameter Dispersion 
Type: Value: 

Estimation Comments  Additional estimates of proportion of 2month 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  pValue  
Comments  
Method  
Comments  
Method of Estimation  Estimation Parameter  proportion 
Estimated Value  0.966  
Confidence Interval 
(2Sided) % to 

Parameter Dispersion 
Type: Value: 

Estimation Comments  Additional estimates of proportion of 2month 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 metricderived #1, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #1 prescription first, followed by the clinically derived, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2 prescription first, followed by the clinically derived, and lastly the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #1 prescription first, followed by the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 metricderived #2 prescription first, followed by the metricderived #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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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  pValue  >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  pValue  
Comments  
Method  
Comments  
Method of Estimation  Estimation Parameter  proportion 
Estimated Value  0.967  
Confidence Interval 
(2Sided) % to 

Parameter Dispersion 
Type: Value: 

Estimation Comments  Additional estimates of proportion of 2month 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  pValue  
Comments  
Method  
Comments  
Method of Estimation  Estimation Parameter  proportion 
Estimated Value  0.967  
Confidence Interval 
(2Sided) % to 

Parameter Dispersion 
Type: Value: 

Estimation Comments  Additional estimates of proportion of 2month 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  pValue  
Comments  
Method  
Comments  
Method of Estimation  Estimation Parameter  proportion 
Estimated Value  0.966  
Confidence Interval 
(2Sided) % to 

Parameter Dispersion 
Type: Value: 

Estimation Comments  Additional estimates of proportion of 2month 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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 postdilation (3  5 captures per eye). Measures will be resized to the patient's habitual pupil diameter and averaged. Postmeasurement 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
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  6142475825 
anderson.3881@osu.edu 
 EY024590