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
211 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official 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 per directions for use
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 unable to maintain eye comfort or adequate vision despite treatment
- Previous corneal or intraocular surgery except cataract surgery
- History of ocular trauma or ocular conditions expected to require retinal laser or other surgery
- Acute, chronic or uncontrolled systemic disease that may confound study outcomes
- Patient is pregnant, plans pregnancy, lactating, or has hormone-related conditions causing refractive changes or dry eye
- Current or recent participation in another clinical trial within 30 days
- Plans to travel, relocate, or be unavailable for study visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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