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.
Study Type
OBSERVATIONAL
Enrollment
250
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.
CREST-XT Site 05
Newport Beach, California, United States
CREST-XT Site 03
Cape Coral, Florida, United States
CREST-XT Site 07
Atlanta, Georgia, United States
CREST-XT Site 12
Mean change in intraocular pressure (IOP)
Mean change in intraocular pressure (IOP) measured using tonometry
Time frame: From before bio-interventional cyclodialysis to 60 months after surgery
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Chevy Chase, Maryland, United States
CREST-XT Site 13
Rockville, Maryland, United States
CREST-XT Site 16
Las Vegas, Nevada, United States
CREST-XT Site 15
New York, New York, United States
CREST-XT Site 01
Fort Washington, Pennsylvania, United States
CREST-XT Site 04
Crossville, Tennessee, United States
CREST-XT Site 11
Salt Lake City, Utah, United States