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

Completed

• Conditions: Cataract
• Interventions: Device: Panoptix

• Registration Number: NCT04124952
• Lead Sponsor: SightTrust Eye Institute

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.

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 Timeline

• Study Start: 2019-10-03
• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-10-11
• Study First Posted: 2019-10-14
• Primary Completion: 2021-02-16
• Study Completion: 2021-02-16
• Results First Submitted: 2021-07-19
• Status Verified: 2021-08
• Results First Submitted QC: 2021-09-07
• Results First Posted: 2021-09-09
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Panoptix	Panoptix	Patients bilaterally implanted with the Panoptix intraocular lens.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Binocular Uncorrected Distance Visual Acuity	3 months	Binocular logMAR uncorrected distance visual acuity
Binocular Uncorrected Intermediate Visual Acuity	3 months	Binocular logMAR uncorrected intermediate visual acuity
Binocular Uncorrected Near Visual Acuity	3 months	Binocular logMAR uncorrected near visual acuity
Residual Refractive Cylinder	3 months	Residual refractive cylinder in diopters
Binocular Corrected Distance Visual Acuity	3 months	Binocular logMAR corrected distance visual acuity
Binocular Distance-corrected Near Visual Acuity	3 months	Binocular logMAR distance-corrected near visual acuity
Spherical Equivalent Refraction	3 months	Spherical equivalent refraction in diopters
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.
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")
Binocular Distance-corrected Intermediate Visual Acuity	3 months	Binocular distance-corrected intermediate visual acuity in logMAR

Trial Locations

Locations (1)

SightTrust Eye Institute; 🇺🇸 Sunrise, Florida, United States