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Study of the CycloPen Micro-Interventional System and Long-Term Clinical Outcomes
Sponsor: Iantrek, Inc.
Summary
This observational study will enroll adults with open angle glaucoma (OAG) who had surgery to reduce intraocular pressure (IOP) using the CycloPen Micro-Interventional System. Consenting participants will be followed for 24 months after their surgery. Data regarding IOP, use of glaucoma medications, and any side effects related to the surgery will be collected from participants' preoperative examination, their surgery, and postoperative examinations.
Official title: An Observational Registry Study of Safety and Effectiveness Outcomes Through 24 Months Postoperatively Following CycloPen™ Micro-Interventional Cyclodialysis System Procedures in Patients With Open Angle Glaucoma
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2022-08-17
Completion Date
2027-08
Last Updated
2025-12-23
Healthy Volunteers
No
Conditions
Interventions
CycloPen Cyclodialysis System
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.
Locations (16)
CREST Site 05
Newport Beach, California, United States
CREST Site 03
Cape Coral, Florida, United States
CREST Site 10
DeLand, Florida, United States
CREST Site 06
Fort Myers, Florida, United States
CREST Site 07
Atlanta, Georgia, United States
CREST Site 12
Chevy Chase, Maryland, United States
CREST Site 13
Rockville, Maryland, United States
CREST Site 16
Las Vegas, Nevada, United States
CREST Site 14
New Brunswick, New Jersey, United States
CREST Site 15
New York, New York, United States
CREST Site 17
Williamsville, New York, United States
CREST Site 01
Fort Washington, Pennsylvania, United States
CREST Site 04
Crossville, Tennessee, United States
CREST Site 09
Fort Worth, Texas, United States
CREST Site 11
Salt Lake City, Utah, United States
CREST Site 301
Panama City, Panama