Multicenter Clinical Trial of a Phakic Implantable Collamer® Lens (ICL)

Last updated: March 5, 2025
Sponsor: Staar Surgical Company
Overall Status: Completed

Phase

N/A

Condition

Myopia

Astigmatism

Treatment

EVO/EVO+ Visian ICL

Clinical Study ID

NCT04283149
CP19-01
  • Ages 21-45
  • All Genders

Study Summary

This objective of this study is to evaluate the safety, and to collect supportive data on effectiveness of the EVO/EVO+ Visian® Implantable Collamer® Lens (ICL) in study participants who have a diagnosis of myopia or myopia with astigmatism. Primary study analysis will be evaluated when 300 primary eyes complete 6 months of follow-up. Final study analysis will be assessed when all treated eyes complete 36 months of follow-up.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Moderate to high myopia or myopic astigmatism correctable with available EVO/EVO+ICL powers.

  • Stable refractive history within 0.50 D each cylinder and spherical equivalent (SE)for 1 year prior to implantation.

  • Able and willing to return for scheduled follow-up examinations after surgery.

  • Able to read, understand and provide written informed consent on the InstitutionalReview Board (IRB)-approved informed consent form (ICF) and provide authorization asappropriate for local privacy regulations.

  • Other protocol-specified inclusion criteria may apply.

Exclusion

Exclusion Criteria:

  • Insulin-dependent diabetes or diabetic retinopathy.

  • History of previous ocular surgery.

  • Cataract of any grade.

  • Monocular.

  • Pregnant or nursing women, or those who plan to become pregnant over the course ofthis clinical study.

  • Other protocol-specified exclusion criteria may apply.

Study Design

Total Participants: 327
Treatment Group(s): 1
Primary Treatment: EVO/EVO+ Visian ICL
Phase:
Study Start date:
January 30, 2020
Estimated Completion Date:
December 15, 2023

Study Description

This study will be conducted at up to 20 clinical sites in the United States by surgeons qualified by training and experience to implant STAAR ICLs.

Connect with a study center

  • Barnett Dulaney Perkins

    Phoenix, Arizona 85106
    United States

    Site Not Available

  • Aloha Laser Vision, LLC

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Price Vision Group,

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Durrie Vision

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Solomon Eye Physicians and Surgeons/Bowie Vision Institute

    Bowie, Maryland 20716
    United States

    Site Not Available

  • Brinton Vision

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Kugler Vision, PC

    Omaha, Nebraska 68118
    United States

    Site Not Available

  • Cleveland Eye Clinic

    Brecksville, Ohio 44141
    United States

    Site Not Available

  • Kremer Eye Center

    King Of Prussia, Pennsylvania 19406
    United States

    Site Not Available

  • Vance Thompson Vision

    Sioux Falls, South Dakota 57108
    United States

    Site Not Available

  • Key-Whitman Eye Center

    Dallas, Texas 75243
    United States

    Site Not Available

  • Parkhurst NuVision

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Hoopes Vision/Hoopes, Durrie, Rivera Research

    Draper, Utah 84020
    United States

    Site Not Available

  • The Eye Institute of Utah

    Salt Lake City, Utah 84107
    United States

    Site Not Available

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