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India PanOptix Post Marketing Study

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT03706066
Collaborator
(none)
80
Enrollment
5
Locations
12.1
Actual Duration (Months)
16
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
80 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
An Observational, Prospective, Post-Marketing Clinical Study of the ACRYSOF® IQ PanOptix Multifocal IOL in an Indian Population
Actual Study Start Date :
Jan 15, 2019
Actual Primary Completion Date :
Jan 18, 2020
Actual Study Completion Date :
Jan 18, 2020

Arms and Interventions

Arm 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

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alcon Investigative Site Ahmedabad Gujarat India 380052
    2 Alcon Investigative Site Chennai Tamil Nadu India 600006
    3 Alcon Investigative Site Coimbatore Tamilnadu India 641002
    4 Alcon Investigative Site Bangalore India 560010
    5 Alcon Investigative Site Hyderabad India 500034

    Sponsors and Collaborators

    • Alcon Research

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT03706066
    Other Study ID Numbers:
    • ILD432-P001
    • CTRI/2018/11/016467
    First Posted:
    Oct 15, 2018
    Last Update Posted:
    Feb 5, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Cataract

    Study Results

    No Results Posted as of Feb 5, 2020