Iantrek, Inc.
This study is designed to collect clinical data at 3, 4, and 5 years postoperatively for participants who completed the CREST Study without having secondary IOP-lowering surgery in the study eye(s).
This is a multicenter, prospective, observational study following eligible participants who completed the CREST Study. Participants who consent to participate will have clinical data gathered from annual ophthalmic examinations through 60 months after CycloPen System surgery for analysis of long-term outcomes. As an observational study, examinations at each visit are performed per the investigator's standard of care.
Inclusion Criteria: 1. Diagnosis of open-angle glaucoma (OAG) in the study eye(s), including pigmentary and pseudoexfoliative glaucoma, at the time of CREST enrollment 2. Completed participation in CREST 3. Provide signed written consent using the Institutional Review Board (IRB)/Ethics Committee (EC) approved study-specific informed consent form (ICF) 4. Ability, comprehension, and willingness to follow study instructions Exclusion Criteria: 1. Systemic disease that, in the opinion of the Investigator, would put participant's health at risk and/or prevent completion of required study visit…
The CycloPen Micro-Interventional Cyclodialysis System is used to create and cyclodialysis cleft and deliver allograft scleral tissue and/or viscous material to reinforce and maintain the cleft postoperatively.
After cataract surgery, the CycloPen Micro-Interventional Cyclodialysis System is used to create and cyclodialysis cleft and deliver allograft scleral tissue and/or viscous material to reinforce and maintain the cleft postoperatively.