IC-8 Apthera IOL New Enrollment Post Approval Study

Last updated: January 16, 2025
Sponsor: Bausch & Lomb Incorporated
Overall Status: Active - Recruiting

Phase

N/A

Condition

Presbyopia

Eye Disorders/infections

Eye Disease

Treatment

N/A

Clinical Study ID

NCT06060041
SAIL-101-PAS2
  • Ages > 22
  • All Genders

Study Summary

The purpose of this study is to verify the post-market safety of the IC-8 Apthera IOL after the treatment of posterior capsular opacification (PCO), an expected complication related to IC-8 Apthera IOL implantation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 22 years of age or older, any race and any gender;

  • Posterior capsule opacification (PCO) requiring treatment in the IC-8 Apthera IOLeye

  • Able to comprehend and have signed a statement of informed consent;

  • Availability, willingness, ability and sufficient cognitive awareness to comply withexamination procedures and study visits;

  • Clear intraocular media in both eyes;

  • Preoperative corneal astigmatism ≤1.5 D in the IC-8 Apthera IOL eye prior to IC-8Apthera implantation;

  • Prior IC-8 Apthera IOL implantation in one eye and a monofocal/monofocal toric IOLin the other eye in accordance with the directions for use (DFU) for each IOL.

Exclusion

Exclusion Criteria:

  • Pharmacologically dilated pupil size less than 7.0 mm in the IC-8 Apthera IOL eye;

  • Irregular astigmatism in either eye;

  • History of retinal disease;

  • Active or recurrent anterior segment pathology;

  • Presence of ocular abnormalities;

  • Diagnosis of dry eye in which patients are unable to maintain eye comfort oradequate vision even with dry eye treatment;

  • Previous corneal or intraocular surgery, except cataract surgery;

  • History of ocular trauma or ocular conditions expected to require retinal lasertreatment or other surgical intervention;

  • Acute, chronic or uncontrolled systemic disease that would, in the opinion of theinvestigator, confound the outcomes of the study;

  • Patient is pregnant, plans to become pregnant, is lactating or has another conditionassociated with hormonal fluctuation that could lead to refractive changes and dryeye;

  • Concurrent participation or participation in any clinical trial up to 30 days priorto the first visit in the study.

  • Subjects who plan to be traveling, relocating or otherwise unavailable to attend anyof the visits

Study Design

Total Participants: 435
Study Start date:
September 08, 2023
Estimated Completion Date:
September 30, 2027

Study Description

Prospective, multi-center, single-group, non-randomized new enrollment post approval study to assess the post-market safety of the IC-8 Apthera IOL after Nd:YAG laser capsulotomy following sufficient surgeon training of the sponsor-recommended standardized Nd:YAG laser capsulotomy technique. All subjects will undergo approximately 6 study visits and will be followed 24 months post IC-8 Apthera IOL implantation. There is one study group: subjects previously implanted with the IC-8 Apthera IOL and who have developed posterior capsular opacification (PCO) which requires treatment with Nd:YAG laser capsulotomy.

Connect with a study center

  • Trinity Research Group, LLC

    Dothan, Alabama 36301
    United States

    Active - Recruiting

  • Reeve Woods Eye Center

    Chico, California 95926
    United States

    Site Not Available

  • Feinerman Vision Center

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • Argus Research Center

    Cape Coral, Florida 33909
    United States

    Active - Recruiting

  • Virdi Eye Clinic and Laser Vision Center

    Rock Island, Illinois 61201
    United States

    Active - Recruiting

  • Price Vision Group

    Indianapolis, Indiana 46260
    United States

    Active - Recruiting

  • Oakland Eye

    Birmingham, Michigan 48009
    United States

    Active - Recruiting

  • Vance Thompson Vision - Alexandria

    Alexandria, Minnesota 56308
    United States

    Site Not Available

  • Vance Thompson Vision - Bozeman

    Bozeman, Montana 59718
    United States

    Site Not Available

  • Vance Thompson Vision - Omaha

    Omaha, Nebraska 68137
    United States

    Active - Recruiting

  • Eye Associates of New Jersey

    Dover, New Jersey 07801
    United States

    Active - Recruiting

  • Northern New Jersey Eye Institute

    South Orange, New Jersey 07079
    United States

    Active - Recruiting

  • Ophthalmic Partners, PC

    Bala-Cynwyd, Pennsylvania 19004
    United States

    Active - Recruiting

  • Berkely Eye Center

    Houston, Texas 77027
    United States

    Site Not Available

  • Berkeley Eye Center

    Sugar Land, Texas 77478
    United States

    Active - Recruiting

  • Utah Eye Centers

    Bountiful, Utah 84010
    United States

    Active - Recruiting

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