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IC-8 Apthera IOL New Enrollment Post Approval Study

RecruitingObservational study

Who can join

Ages 22 and older · All sexes

Full eligibility criteria
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

About the study

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.

Sponsor: Bausch & Lomb Incorporated · Participants: 435 · Started: Sep 8, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT06060041

Locations in the U.S.

AlabamaTrinity Research Group, LLC, Dothan
CaliforniaFeinerman Vision Center, Newport Beach
FloridaArgus Research Center, Cape Coral
Stephenson Eye Associates, Venice
IllinoisVirdi Eye Clinic and Laser Vision Center, Rock Island
IndianaPrice Vision Group, Indianapolis
KansasGrene Vision Group, Wichita
MichiganOakland Eye, Birmingham
NebraskaVance Thompson Vision - Omaha, Omaha
New JerseyEye Associates of New Jersey, Dover
Northern New Jersey Eye Institute, South Orange
PennsylvaniaOphthalmic Partners, PC, Bala-Cynwyd
TexasBerkeley Eye Center, Sugar Land
UtahUtah Eye Centers, Bountiful

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.