India PanOptix Post Marketing Study

Study Overview
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Brief Summary
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The purpose of this Post Marketing Study is to study the safety and effectiveness of the ACRYSOF IQ PanOptix intraocular lens (IOL) in an Indian population.

Detailed Description
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The study population will consist of adult Indian males and females, at least 18 years of age or older at the time of screening, with no ocular pathology that could confound study outcomes, who are advised bilateral cataract extraction and who desire an IOL that provides the potential for correction of near, intermediate, and distance vision. Both eyes will be implanted. The second eye surgery will take place 15-30 days after the first eye surgery. Subjects will be followed for approximately 3 months after the second eye surgery. Total individual subject participation will be approximately 4 months. This study will be conducted in India.

Official Title
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An Observational, Prospective, Post-Marketing Clinical Study of the ACRYSOF® IQ PanOptix Multifocal IOL in an Indian Population

Conditions
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Cataract

Intervention / Treatment
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* Device: Acrysof IQ PanOptix IOL
* Procedure: Cataract surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures; Advised cataract extraction in both eyes and agreed for bilateral implantation of ACRYSOF IQ PanOptix lens; Preoperative regular keratometric astigmatism of ≤1.0 D in both eyes. Exclusion Criteria: Pregnant or lactating, current or planned, during the course of the study; Retinal abnormalities (Macular Degeneration, dystrophy, edema , traction or other pathologies affecting vision); Clinically significant corneal abnormalities; History of retinal conditions; Previous refractive surgery, including LASIK; Glaucoma; Any condition that may not be appropriate to this study, as per the Investigator's expert medical opinion. Other protocol-specified inclusion and/or exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PanOptix<br>Cataract surgery with implantation of Acrysof IQ PanOptix IOL | Device: Acrysof IQ PanOptix IOL<br>* Single-piece, ultraviolet and blue-light filtering, foldable, multifocal intraocular lens (IOL) inserted into the capsular bag during cataract surgery<br>* Other names: Model TFNT00;Procedure: Cataract surgery<br>* Per investigator's standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected binocular visual acuity at distance (4 m) at 3 months post bilateral implantation | Visual acuity will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) charts and reported in logarithm minimum angle of resolution (logMAR). | Month 3 (following second eye surgery) |