RecruitingNCT06060041

IC-8 Apthera IOL New Enrollment Post Approval Study


Sponsor

Bausch & Lomb Incorporated

Enrollment

435 participants

Start Date

Sep 8, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 22 Years

Inclusion Criteria7

  • years of age or older, any race and any gender;
  • Posterior capsule opacification (PCO) requiring treatment in the IC-8 Apthera IOL eye
  • Able to comprehend and have signed a statement of informed consent;
  • Availability, willingness, ability and sufficient cognitive awareness to comply with examination 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-8 Apthera implantation;
  • Prior IC-8 Apthera IOL implantation in one eye and a monofocal/monofocal toric IOL in the other eye in accordance with the directions for use (DFU) for each IOL.

Exclusion Criteria12

  • 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 or adequate 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 laser treatment or other surgical intervention;
  • Acute, chronic or uncontrolled systemic disease that would, in the opinion of the investigator, confound the outcomes of the study;
  • Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with hormonal fluctuation that could lead to refractive changes and dry eye;
  • Concurrent participation or participation in any clinical trial up to 30 days prior to the first visit in the study.
  • Subjects who plan to be traveling, relocating or otherwise unavailable to attend any of the visits

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Locations(14)

Trinity Research Group, LLC

Dothan, Alabama, United States

Feinerman Vision Center

Newport Beach, California, United States

Argus Research Center

Cape Coral, Florida, United States

Stephenson Eye Associates

Venice, Florida, United States

Virdi Eye Clinic and Laser Vision Center

Rock Island, Illinois, United States

Price Vision Group

Indianapolis, Indiana, United States

Grene Vision Group

Wichita, Kansas, United States

Oakland Eye

Birmingham, Michigan, United States

Vance Thompson Vision - Omaha

Omaha, Nebraska, United States

Eye Associates of New Jersey

Dover, New Jersey, United States

Northern New Jersey Eye Institute

South Orange, New Jersey, United States

Ophthalmic Partners, PC

Bala-Cynwyd, Pennsylvania, United States

Berkeley Eye Center

Sugar Land, Texas, United States

Utah Eye Centers

Bountiful, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT06060041


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