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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
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.
This is a multicenter, observational registry of eligible adults with open angle glaucoma (OAG) in whom IOP-lowering surgery with the CycloPen Micro-Interventional System was performed are consecutively enrolled. Data will be collected from the preoperative visit(s) that directly preceded surgery, the surgical procedure, and postoperative visits through 24 months after CycloPen System use. Specific data to be collected includes details of the CycloPen surgical procedure, IOP, use of ocular hypotensive medications, and any side effects related to the surgery.
Age
21 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
August 17, 2022
Primary Completion Date
August 1, 2026
Completion Date
August 1, 2027
Last Updated
December 23, 2025
300
ESTIMATED participants
CycloPen Cyclodialysis System
DEVICE
Lead Sponsor
Iantrek, Inc.
NCT07396441
NCT07390890
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05902871