Phase
Condition
Presbyopia
Eye Disorders/infections
Eye Disease
Treatment
N/AClinical Study ID
Ages > 22 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
22 years of age or older, any race and any gender;
Posterior capsule opacification (PCO) requiring treatment in the IC-8 Apthera IOLeye
Able to comprehend and have signed a statement of informed consent;
Availability, willingness, ability and sufficient cognitive awareness to comply withexamination 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-8Apthera implantation;
Prior IC-8 Apthera IOL implantation in one eye and a monofocal/monofocal toric IOLin the other eye in accordance with the directions for use (DFU) for each IOL.
Exclusion
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 oradequate 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 lasertreatment or other surgical intervention;
Acute, chronic or uncontrolled systemic disease that would, in the opinion of theinvestigator, confound the outcomes of the study;
Patient is pregnant, plans to become pregnant, is lactating or has another conditionassociated with hormonal fluctuation that could lead to refractive changes and dryeye;
Concurrent participation or participation in any clinical trial up to 30 days priorto the first visit in the study.
Subjects who plan to be traveling, relocating or otherwise unavailable to attend anyof the visits
Study Design
Study Description
Connect with a study center
Trinity Research Group, LLC
Dothan, Alabama 36301
United StatesActive - Recruiting
Reeve Woods Eye Center
Chico, California 95926
United StatesSite Not Available
Feinerman Vision Center
Newport Beach, California 92663
United StatesActive - Recruiting
Argus Research Center
Cape Coral, Florida 33909
United StatesActive - Recruiting
Virdi Eye Clinic and Laser Vision Center
Rock Island, Illinois 61201
United StatesActive - Recruiting
Price Vision Group
Indianapolis, Indiana 46260
United StatesActive - Recruiting
Oakland Eye
Birmingham, Michigan 48009
United StatesActive - Recruiting
Vance Thompson Vision - Alexandria
Alexandria, Minnesota 56308
United StatesSite Not Available
Vance Thompson Vision - Bozeman
Bozeman, Montana 59718
United StatesSite Not Available
Vance Thompson Vision - Omaha
Omaha, Nebraska 68137
United StatesActive - Recruiting
Eye Associates of New Jersey
Dover, New Jersey 07801
United StatesActive - Recruiting
Northern New Jersey Eye Institute
South Orange, New Jersey 07079
United StatesActive - Recruiting
Ophthalmic Partners, PC
Bala-Cynwyd, Pennsylvania 19004
United StatesActive - Recruiting
Berkely Eye Center
Houston, Texas 77027
United StatesSite Not Available
Berkeley Eye Center
Sugar Land, Texas 77478
United StatesActive - Recruiting
Utah Eye Centers
Bountiful, Utah 84010
United StatesActive - Recruiting
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