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ENROLLING BY INVITATION
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

2027-08

Last Updated

2025-12-23

Healthy Volunteers

No

Interventions

DEVICE

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