Visual Performance With Clareon® Vivity® Intraocular Lenses (IOLs)

Last updated: July 18, 2025
Sponsor: Alcon Research
Overall Status: Completed

Phase

N/A

Condition

Astigmatism

Treatment

Clareon Vivity Extended Vision IOL

Clinical Study ID

NCT06784063
ILE632-C003
  • Ages > 22
  • All Genders

Study Summary

The purpose of this study is to generate clinical data to quantify the impact of residual astigmatism on the overall visual performance during distance, intermediate, and near viewing in patients implanted with Clareon Vivity IOLs.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Able to understand and sign an Institution Review Board-approved informed consentform;

  • Willing and able to attend all scheduled study visits as required by the protocol;

  • Implanted with study IOLs in both eyes at least 4 months prior to studyparticipation;

  • BCDVA of 0 logMAR or better in each eye.

Exclusion

Exclusion Criteria:

  • Residual astigmatism greater than or equal to 1.00 D;

  • Clinically significant ocular conditions as specified in the protocol;

  • History of ocular surgeries other than limbal relaxing incisions

  • Other protocol-specified exclusion criteria may apply.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Clareon Vivity Extended Vision IOL
Phase:
Study Start date:
April 10, 2025
Estimated Completion Date:
June 13, 2025

Study Description

This single visit study is designed to help understand how vision is affected if the eye still has astigmatism after cataract surgery. Participants will be individuals who have already undergone cataract surgery and received a Clareon Vivity IOL in both eyes at least 4 months prior to study enrollment. During the study visit, trial lenses (glass lenses that are used during an eye exam) will be used to temporarily create the effect of astigmatism on the eye.

Connect with a study center

  • Grosinger, Spigelman & Grey Eye Surgeons, P.C

    Bloomfield Hills, Michigan 48302
    United States

    Site Not Available

  • Key-Whitman Eye Center

    Dallas, Texas 75243
    United States

    Site Not Available

  • Contact Alcon Call Center for Trial Locations

    Fort Worth, Texas 76134
    United States

    Site Not Available

  • Berkeley Eye Center

    Sugar Land, Texas 77478
    United States

    Site Not Available

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