NCT06060041 · Bausch & Lomb Incorporated
IC-8 Apthera IOL New Enrollment Post Approval Study
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Dothan, Alabama
- Newport Beach, California
- Cape Coral, Florida
- Venice, Florida
- Rock Island, Illinois
- Indianapolis, Indiana
- Wichita, Kansas
- Birmingham, Michigan
- Omaha, Nebraska
- Dover, New Jersey
- South Orange, New Jersey
- Bala-Cynwyd, Pennsylvania
And 2 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 12, 2026 · Source of record for eligibility and locations