India PanOptix Post Marketing Study

Completed

• Conditions: Cataract
• Interventions: Device: Acrysof IQ PanOptix IOL; Procedure: Cataract surgery

• Registration Number: NCT03706066
• Lead Sponsor: Alcon Research

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-10-11
• Study First Posted: 2018-10-15
• Study Start: 2019-01-15
• Primary Completion: 2020-01-18
• Study Completion: 2020-01-18
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PanOptix	Acrysof IQ PanOptix IOL	Cataract surgery with implantation of Acrysof IQ PanOptix IOL
PanOptix	Cataract surgery	Cataract surgery with implantation of Acrysof IQ PanOptix IOL

Primary Outcome Measures

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

Trial Locations

Locations (1)

Alcon Investigative Site; 🇮🇳 Hyderabad, India