India PanOptix Post Marketing Study

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Acrysof IQ PanOptix IOL; Procedure: Cataract surgery

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• India
  • Bangalore, India, 560010
    • Alcon Investigative Site
  • Hyderabad, India, 500034
    • Alcon Investigative Site
  • Gujarat
    • Ahmedabad, Gujarat, India, 380052
      • Alcon Investigative Site
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600006
      • Alcon Investigative Site
  • Tamilnadu
    • Coimbatore, Tamilnadu, India, 641002
      • Alcon Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study will enroll males and females who are at least 18 years of age or older at the time of screening, have no ocular pathology that could confound study outcomes, have been advised bilateral cataract extraction, and desire an intraocular lens (IOL) that provides the potential for correction of near, intermediate, and distance vision.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Study Director, Alcon Laboratories (India) PVT.LTD

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2019
• Primary Completion (ACTUAL): January 18, 2020
• Study Completion (ACTUAL): January 18, 2020

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 11, 2018
• First Posted (ACTUAL): October 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: ILD432-P001; CTRI/2018/11/016467 (OTHER: CTRI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes