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ACTIVE NOT RECRUITING
NCT05506423

Study of the CycloPen Micro-Interventional System and Long-Term Clinical Outcomes

Sponsor: Iantrek, Inc.

View on ClinicalTrials.gov

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

2027-12

Last Updated

2026-07-22

Healthy Volunteers

No

Interventions

DEVICE

CycloPen Cyclodialysis System

The CycloPen Micro-Interventional Cyclodialysis System is used to create a cyclodialysis cleft and deliver allograft scleral tissue and/or viscous material within the cleft for endoscleral reinforcement.

Locations (16)

Visionary Eye Institute

Newport Beach, California, United States

Tyson Eye

Cape Coral, Florida, United States

Central Florida Eye Specialists

DeLand, Florida, United States

Eye Associates of Ft. Myers

Fort Myers, Florida, United States

Omni Eye Services

Atlanta, Georgia, United States

Eye Doctors of Washington

Chevy Chase, Maryland, United States

Visionary Eye Doctors

Rockville, Maryland, United States

Center for Sight

Las Vegas, Nevada, United States

Wilton Center for Advanced Eyecare

New Brunswick, New Jersey, United States

North Manhattan Eye Center

New York, New York, United States

Buffalo Ophthalmology

Williamsville, New York, United States

James S Lewis, MD

Fort Washington, Pennsylvania, United States

Eye Centers of Tennessee

Crossville, Tennessee, United States

Ophthalmology Associates

Fort Worth, Texas, United States

John Moran Eye Center - U of Utah

Salt Lake City, Utah, United States

Panama Eye Center

Panama City, Panama