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OpenTrials
Completed

NCT Number: NCT03706066

India PanOptix Post Marketing Study

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alcon Investigative Site, Ahmedabad, Gujarat, India

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acrysof IQ PanOptix IOL

Device

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

Other names: Model TFNT00

cataract surgery

Procedure

Per investigator's standard of care

Primary outcomes

  1. Best corrected binocular visual acuity at distance (4 m) at 3 months post bilateral implantation

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 15, 2018
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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