AcrySof® Bilateral PanOptix(R) Spectacle Freedom and Patient Satisfaction Study

Completed

• Conditions: Cataract
• Interventions: Device: Panoptix

• Registration Number: NCT04126187
• Lead Sponsor: Gainesville Eye Associates

Brief Summary

The objective of this study is to assess the spectacle independence 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 First Submitted: 2019-10-11
• Study First Submitted QC: 2019-10-11
• Study First Posted: 2019-10-15
• Study Start: 2020-05-14
• Primary Completion: 2021-03-30
• Study Completion: 2021-03-30
• Results First Submitted: 2021-07-19
• Results First Submitted QC: 2021-07-19
• Results First Posted: 2021-08-11
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-19
• Last Update Posted: 2023-09-21

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	Bilateral implantation of the Panoptix trifocal IOL

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Have Spectacle Independence	3 months	Percent of patients 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 uncorrected distance visual acuity in logMAR
Binocular Best-corrected Distance Visual Acuity	3 months	Binocular logMAR best-corrected distance visual acuity
Binocular Uncorrected Near Visual Acuity	3 months	Binocular logMAR uncorrected near visual acuity
Binocular Distance-corrected Intermediate Visual Acuity	3 months	Binocular distance-corrected logMAR intermediate visual acuity
Binocular Uncorrected Intermediate Visual Acuity	3 months	Binocular uncorrected intermediate visual acuity in logMAR
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
Residual Refractive Cylinder	3 months	Residual refractive cylinder in diopters
Number of Participants Who Are Spectacle Independent in the Emmetropia Subgroup	3 months	Spectacle independence of subjects that hit refractive target within 0.5 diopters (D) spherical equivalent refraction

Trial Locations

Locations (1)

Gainesville Eye Associates; 🇺🇸 Gainesville, Georgia, United States