A Real-World Evidence (RWE) Long-Term Follow-Up Study to Assess Outcomes of Alcon Monofocal Intraocular Lenses

Last updated: May 19, 2025
Sponsor: Alcon Research
Overall Status: Active - Enrolling

Phase

N/A

Condition

N/A

Treatment

AcrySof multi-piece IOL

AcrySof single-piece IOL

Clinical Study ID

NCT05799950
ILB609-N001
  • All Genders

Study Summary

The purpose of this post-market clinical follow-up (PMCF) study is to describe the long-term safety and performance of AcrySof Single-Piece and AcrySof Multi-Piece monofocal intraocular lenses (IOLs).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Subject is implanted with one of the study IOL models between 3 and 5 yearspreviously.

  • Subject follow-up is expected to be possible during the duration of the study.

  • Subject or legally authorized representative must be able to understand and sign theIRB/EC approved Informed Consent form. Minor subjects will complete an Assent Form.

  • Documented medical history and required pre-operative baseline information isavailable for retrospective data collection.

Exclusion

Key Exclusion Criteria:

  • Subject is participating in a separate investigational drug or device study.

  • Pregnancy at the time of enrollment.

Study Design

Total Participants: 230
Treatment Group(s): 2
Primary Treatment: AcrySof multi-piece IOL
Phase:
Study Start date:
August 28, 2023
Estimated Completion Date:
June 30, 2025

Study Description

The study includes a retrospective chart review for pre-operative, operative, and post-operative data collection, and a prospective, standard-of-care visit to collect study endpoints.

Connect with a study center

  • Centro Oftalmologico Metropolitano

    San Juan, 00921
    Puerto Rico

    Site Not Available

  • Velvet Clinical Research

    Burbank, California 91506
    United States

    Site Not Available

  • Levenson Eye Associates

    Jacksonville, Florida 32204
    United States

    Site Not Available

  • Virdi Eye Clinic

    Rock Island, Illinois 61201
    United States

    Site Not Available

  • SightMD

    Babylon, New York 11702
    United States

    Site Not Available

  • Texan Eye

    Austin, Texas 78731
    United States

    Site Not Available

  • Chu Eye Institute

    Fort Worth, Texas 76107
    United States

    Site Not Available

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