Evaluation of Quality of Vision and Spectacle Independence With the AcrySof® Panoptix® Intraocular Lens

Sponsor
SightTrust Eye Institute (Other)
Overall Status
Completed
CT.gov ID
NCT04124952
Collaborator
Science in Vision (Other)
30
Enrollment
1
Location
16.5
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a study to assess the spectacle independence and quality of vision of patients receiving the AcrySof® Panoptix® Intraocular lens (IOL) after uneventful cataract surgery.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Panoptix

Detailed Description

This study is a single-arm unmasked clinical evaluation study of spectacle independence after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a spectacle independence questionnaire, as well as measurement of bilateral visual acuity and manifest refraction.

Study Design

Study Type:
Observational
Actual Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Quality of Vision and Spectacle Independence With Bilateral Implantation of the AcrySof® Panoptix® Intraocular Lens
Actual Study Start Date :
Oct 3, 2019
Actual Primary Completion Date :
Feb 16, 2021
Actual Study Completion Date :
Feb 16, 2021

Arms and Interventions

ArmIntervention/Treatment
Panoptix

Patients bilaterally implanted with the Panoptix intraocular lens.

Device: Panoptix
Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)

Outcome Measures

Primary Outcome Measures

  1. Number of Emmetropic Subjects Who Are Spectacle Independent [3 months]

    Number of patients who have a 3-month postoperative manifest spherical equivalent refraction within 0.5 diopters (D) of plano, and ≤ 0.5 D of refractive cylinder (emmetropic subgroup) who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire (PRSIQ) - "a little of the time" or "none of the time").

Secondary Outcome Measures

  1. Binocular Uncorrected Distance Visual Acuity [3 months]

    Binocular logMAR uncorrected distance visual acuity

  2. Binocular Uncorrected Intermediate Visual Acuity [3 months]

    Binocular logMAR uncorrected intermediate visual acuity

  3. Binocular Uncorrected Near Visual Acuity [3 months]

    Binocular logMAR uncorrected near visual acuity

  4. Binocular Corrected Distance Visual Acuity [3 months]

    Binocular logMAR corrected distance visual acuity

  5. Binocular Distance-corrected Intermediate Visual Acuity [3 months]

    Binocular distance-corrected intermediate visual acuity in logMAR

  6. Binocular Distance-corrected Near Visual Acuity [3 months]

    Binocular logMAR distance-corrected near visual acuity

  7. Spherical Equivalent Refraction [3 months]

    Spherical equivalent refraction in diopters

  8. Residual Refractive Cylinder [3 months]

    Residual refractive cylinder in diopters

  9. Quality of Vision Questionnaire [3 months]

    Quality of Vision questionnaire results. This is a Rasch-scaled test with scores from 0-100, with lower being better.

  10. Overall Spectacle Independence [3 months]

    percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the PRSIQ - "a little of the time" or "none of the time")

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All

Inclusion Criteria

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

  • Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using a multifocal IOL or multifocal toric IOL option

  • Gender: Males and Females.

  • Age: 40 or older.

  • Willing and able to provide written informed consent for participation in the study.

  • Willing and able to comply with scheduled visits and other study procedures.

  • Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)

  • Have regular corneal astigmatism with a magnitude that can be treated with a non-toric IOL or a toric IOL in the approved ranged for the Panoptix lens.

  • Have 20/32 (0.2 logMAR) or better potential acuity in both eyes

Exclusion Criteria If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

  • Irregular astigmatism (e.g. keratoconus)

  • Corneal pathology (e.g. scar, dystrophy, pterygium, severe dry eye)

  • Monocular status (e.g. amblyopia)

  • Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, lamellar keratoplasty)

  • Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)

  • Diabetic retinopathy

  • Macular pathology (e.g. age-related macular degeneration, epiretinal membrane)

  • History of retinal detachment

  • Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity.

  • Participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating).

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1SightTrust Eye InstituteSunriseFloridaUnited States33323

Sponsors and Collaborators

  • SightTrust Eye Institute
  • Science in Vision

Investigators

  • Principal Investigator: Andrew C Shatz, MD, SightTrust Eye Institute

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
SightTrust Eye Institute
ClinicalTrials.gov Identifier:
NCT04124952
Other Study ID Numbers:
  • AS-19-001
First Posted:
Oct 14, 2019
Last Update Posted:
Sep 9, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by SightTrust Eye Institute
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitlePanoptix
Arm/Group DescriptionPatients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Period Title: Overall Study
STARTED30
COMPLETED29
NOT COMPLETED1

Baseline Characteristics

Arm/Group TitlePanoptix
Arm/Group DescriptionPatients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Overall Participants29
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
58
(7)
Sex: Female, Male (Count of Participants)
Female
17
58.6%
Male
12
41.4%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States
29
100%

Outcome Measures

1. Primary Outcome
TitleNumber of Emmetropic Subjects Who Are Spectacle Independent
DescriptionNumber of patients who have a 3-month postoperative manifest spherical equivalent refraction within 0.5 diopters (D) of plano, and ≤ 0.5 D of refractive cylinder (emmetropic subgroup) who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire (PRSIQ) - "a little of the time" or "none of the time").
Time Frame3 months

Outcome Measure Data

Analysis Population Description
This is the number of emmetropic subjects (subgroup)
Arm/Group TitlePanoptix
Arm/Group DescriptionPatients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Measure Participants21
Count of Participants [Participants]
21
72.4%
2. Secondary Outcome
TitleBinocular Uncorrected Distance Visual Acuity
DescriptionBinocular logMAR uncorrected distance visual acuity
Time Frame3 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePanoptix
Arm/Group DescriptionPatients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Measure Participants29
Mean (Standard Deviation) [logMAR]
0.07
(0.09)
3. Secondary Outcome
TitleBinocular Uncorrected Intermediate Visual Acuity
DescriptionBinocular logMAR uncorrected intermediate visual acuity
Time Frame3 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePanoptix
Arm/Group DescriptionPatients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Measure Participants29
Mean (Standard Deviation) [logMAR]
0.09
(0.13)
4. Secondary Outcome
TitleBinocular Uncorrected Near Visual Acuity
DescriptionBinocular logMAR uncorrected near visual acuity
Time Frame3 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePanoptix
Arm/Group DescriptionPatients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Measure Participants29
Mean (Standard Deviation) [logMAR Acuity]
0.07
(0.11)
5. Secondary Outcome
TitleBinocular Corrected Distance Visual Acuity
DescriptionBinocular logMAR corrected distance visual acuity
Time Frame3 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePanoptix
Arm/Group DescriptionPatients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Measure Participants29
Mean (Standard Deviation) [logMAR Acuity]
0.03
(0.07)
6. Secondary Outcome
TitleBinocular Distance-corrected Intermediate Visual Acuity
DescriptionBinocular distance-corrected intermediate visual acuity in logMAR
Time Frame3 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePanoptix
Arm/Group DescriptionPatients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Measure Participants29
Mean (Standard Deviation) [logMAR Acuity]
0.06
(0.10)
7. Secondary Outcome
TitleBinocular Distance-corrected Near Visual Acuity
DescriptionBinocular logMAR distance-corrected near visual acuity
Time Frame3 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePanoptix
Arm/Group DescriptionPatients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Measure Participants29
Mean (Standard Deviation) [logMAR Acuity]
0.05
(0.11)
8. Secondary Outcome
TitleSpherical Equivalent Refraction
DescriptionSpherical equivalent refraction in diopters
Time Frame3 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePanoptix
Arm/Group DescriptionPatients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Measure Participants29
Mean (Standard Deviation) [diopters]
0.06
(0.53)
9. Secondary Outcome
TitleResidual Refractive Cylinder
DescriptionResidual refractive cylinder in diopters
Time Frame3 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePanoptix
Arm/Group DescriptionPatients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Measure Participants29
Mean (Standard Deviation) [diopters]
0.49
(0.36)
10. Secondary Outcome
TitleQuality of Vision Questionnaire
DescriptionQuality of Vision questionnaire results. This is a Rasch-scaled test with scores from 0-100, with lower being better.
Time Frame3 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePanoptix
Arm/Group DescriptionPatients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Measure Participants29
Frequency
36.9
(16.6)
Severity
30.6
(15.1)
Degree of bother
28.7
(20.7)
11. Secondary Outcome
TitleOverall Spectacle Independence
Descriptionpercent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the PRSIQ - "a little of the time" or "none of the time")
Time Frame3 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitlePanoptix
Arm/Group DescriptionPatients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Measure Participants29
Count of Participants [Participants]
29
100%

Adverse Events

Time Frame3 months
Adverse Event Reporting Description
Arm/Group TitlePanoptix
Arm/Group DescriptionPatients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
All Cause Mortality
Panoptix
Affected / at Risk (%)# Events
Total0/30 (0%)
Serious Adverse Events
Panoptix
Affected / at Risk (%)# Events
Total0/30 (0%)
Other (Not Including Serious) Adverse Events
Panoptix
Affected / at Risk (%)# Events
Total1/30 (3.3%)
Musculoskeletal and connective tissue disorders
Bicycle accident1/30 (3.3%) 1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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/TitleAndrew Shatz, MD
OrganizationSightTrust Eye Institute
Phone877.878.7890
Emailashatz@sighttrust.com
Responsible Party:
SightTrust Eye Institute
ClinicalTrials.gov Identifier:
NCT04124952
Other Study ID Numbers:
  • AS-19-001
First Posted:
Oct 14, 2019
Last Update Posted:
Sep 9, 2021
Last Verified:
Aug 1, 2021