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IC-8 Apthera IOL New Enrollment Post Approval Study | Clinical Trials | Clareo Health

RECRUITING

IC-8 Apthera IOL New Enrollment Post Approval Study

NCT06060041•Bausch & Lomb Incorporated

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.

Detailed 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.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•22 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 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 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;
+2 more criteria

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

Key Dates

Start Date

September 8, 2023

Primary Completion Date

September 30, 2027

Completion Date

September 30, 2027

Last Updated

January 12, 2026

Enrollment

435

ESTIMATED participants

Conditions

CataractPresbyopiaPosterior Capsule Opacification

Contacts

Jennifer Laskowski

CONTACT

8183699137 jennifer.laskowski@bausch.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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IC-8 Apthera IOL New Enrollment Post Approval Study

Inclusion Criteria

Exclusion Criteria

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