Actively Recruiting
IC-8 Apthera IOL New Enrollment Post Approval Study
Led by Bausch & Lomb Incorporated · Updated on 2026-01-12
435
Participants Needed
14
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of the IC-8 Apthera intraocular lens (IOL) after treatment for posterior capsular opacification (PCO), a common complication following IC-8 Apthera IOL implantation. This prospective, multi-center, non-randomized study focuses on patients who have already received the IC-8 Apthera IOL and now require Nd:YAG laser capsulotomy for PCO. The study aims to verify post-market safety following training in a standardized laser treatment technique. Participants previously implanted with the IC-8 Apthera IOL and experiencing PCO will be treated with Nd:YAG laser capsulotomy using a sponsor-recommended method. There is one study group, and subjects will be followed for 24 months after their IC-8 Apthera IOL implantation. The study includes about six visits over this two-year period to monitor safety and treatment outcomes. During the study, participants will undergo assessments of laser treatment outcomes, any complications, and IOL-related evaluations. Researchers will track additional laser treatments, secondary surgical interventions, ocular and serious adverse events, and subjective visual disturbances using specific questionnaires. The study lasts for two years post-implantation, with regular visits to ensure thorough monitoring of participant eye health and treatment effects.
CONDITIONS
Brief Title
IC-8 Apthera IOL New Enrollment Post Approval Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 641.5 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 months
Participants are observed after IC-8 Apthera IOL implantation and Nd:YAG laser capsulotomy to assess safety and outcomes.
Approximately 6 study visits
Trial Site Locations
Total: 14 locations
1
Trinity Research Group, LLC
Dothan, Alabama, United States, 36301
Actively Recruiting
2
Feinerman Vision Center
Newport Beach, California, United States, 92663
Actively Recruiting
3
Argus Research Center
Cape Coral, Florida, United States, 33909
Actively Recruiting
4
Stephenson Eye Associates
Venice, Florida, United States, 34285
Actively Recruiting
5
Virdi Eye Clinic and Laser Vision Center
Rock Island, Illinois, United States, 61201
Actively Recruiting
6
Price Vision Group
Indianapolis, Indiana, United States, 46260
Actively Recruiting
7
Grene Vision Group
Wichita, Kansas, United States, 67206
Actively Recruiting
8
Oakland Eye
Birmingham, Michigan, United States, 48009
Actively Recruiting
9
Vance Thompson Vision - Omaha
Omaha, Nebraska, United States, 68137
Actively Recruiting
10
Eye Associates of New Jersey
Dover, New Jersey, United States, 07801
Actively Recruiting
11
Northern New Jersey Eye Institute
South Orange, New Jersey, United States, 07079
Actively Recruiting
12
Ophthalmic Partners, PC
Bala-Cynwyd, Pennsylvania, United States, 19004
Actively Recruiting
13
Berkeley Eye Center
Sugar Land, Texas, United States, 77478
Actively Recruiting
14
Utah Eye Centers
Bountiful, Utah, United States, 84010
Actively Recruiting
Research Team
J
Jennifer Laskowski
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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