India PanOptix Post Marketing Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-15

Study Completion Date

2020-01-18

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.

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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.

Conditions

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Cataract

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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PanOptix

Cataract surgery with implantation of Acrysof IQ PanOptix IOL

Acrysof IQ PanOptix IOL

Intervention Type DEVICE

Single-piece, ultraviolet and blue-light filtering, foldable, multifocal intraocular lens (IOL) inserted into the capsular bag during cataract surgery

Cataract surgery

Intervention Type PROCEDURE

Per investigator's standard of care

Interventions

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Acrysof IQ PanOptix IOL

Single-piece, ultraviolet and blue-light filtering, foldable, multifocal intraocular lens (IOL) inserted into the capsular bag during cataract surgery

Intervention Type DEVICE

Cataract surgery

Per investigator's standard of care

Intervention Type PROCEDURE

Other Intervention Names

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Model TFNT00

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No