Recruiting

IC-8 Apthera

Sponsor:

Bausch & Lomb Incorporated

Code:

NCT06060041

Conditions

Cataract

Presbyopia

Posterior Capsule Opacification

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Cataract

Presbyopia

Posterior Capsule Opacification

Study ID

NCT06060041

Start date

Sep 8, 2023

Status verified date

Jan, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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;
  • 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

Study Design

Enrollment

435 participants

Anticipated

Interventions and Outcome Measures

Arms

IC-8 Apthera intraocular lens (IOL) Group

Patients previously implanted with the IC-8 Apthera intraocular lens (IOL) and who have developed posterior capsular opacification (PCO) which requires treatment with Nd:YAG laser capsulotomy.

Primary outcome measure

  • Rate of any additional Nd:YAG laser treatments beyond the initial Nd:YAG laser treatment [ Time Frame: 24 Months post IC-8 Apthera IOL Implantation ]
  • Nd:YAG laser treatment outcome and/or complications [ Time Frame: 24 Months post IC-8 Apthera IOL Implantation ]
  • IOL related assessments [ Time Frame: 24 Months post IC-8 Apthera IOL implantation ]
  • Rates of Secondary Surgical Interventions (SSIs) [ Time Frame: 24 Months post IC-8 Apthera IOL implantation ]
  • Rates of other serious adverse events [ Time Frame: 24 Months post IC-8 Apthera IOL implantation ]
  • Rates of ocular adverse events [ Time Frame: 24 Months post IC-8 Apthera IOL implantation ]
  • Rates of subjective visual disturbances per the Quality of Vision (QoV) Questionnaire [ Time Frame: 24 Months post IC-8 Apthera IOL implantation ]
  • Rates of subjective visual disturbances per the Small Aperture Patient Questionnaire (SAPQ) [ Time Frame: 24 Months post IC-8 Apthera IOL implantation ]

Central Contacts and Locations

Central contacts

Jennifer Laskowski

8183699137jennifer.laskowski@bausch.com

Locations

Trinity Research Group, LLC

Recruiting

Dothan, Alabama, United States, 36301

Feinerman Vision Center

Recruiting

Newport Beach, California, United States, 92663

Argus Research Center

Recruiting

Cape Coral, Florida, United States, 33909

Stephenson Eye Associates

Recruiting

Venice, Florida, United States, 34285

Virdi Eye Clinic and Laser Vision Center

Recruiting

Rock Island, Illinois, United States, 61201

Price Vision Group

Recruiting

Indianapolis, Indiana, United States, 46260

Grene Vision Group

Recruiting

Wichita, Kansas, United States, 67206

Oakland Eye

Recruiting

Birmingham, Michigan, United States, 48009

Vance Thompson Vision - Omaha

Recruiting

Omaha, Nebraska, United States, 68137

Eye Associates of New Jersey

Recruiting

Dover, New Jersey, United States, 07801

Northern New Jersey Eye Institute

Recruiting

South Orange, New Jersey, United States, 07079

Ophthalmic Partners, PC

Recruiting

Bala-Cynwyd, Pennsylvania, United States, 19004

Berkeley Eye Center

Recruiting

Sugar Land, Texas, United States, 77478

Utah Eye Centers

Recruiting

Bountiful, Utah, United States, 84010

More Information

Sponsor

Bausch & Lomb Incorporated

Last update posted

Jan 12, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Bausch & Lomb Incorporated on 2026-01-12.