IC-8 Apthera IOL New Enrollment Post Approval Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorBausch & Lomb Incorporated
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Not listed
Trial groups
435 Participants
are grouped into 1 trial groupLocations
14Alabama
Trinity Research Group, LLC36301, Dothan United States
California
Feinerman Vision Center92663, Newport Beach United States
Florida
Argus Research Center33909, Cape Coral United States
Stephenson Eye Associates34285, Venice United States
Sponsors and collaborators
Bausch & Lomb Incorporated
Lead sponsor
Source ClinicalTrials.gov