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 groupSponsors and collaborators
Source ClinicalTrials.gov