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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Panama Eye Center, Panama City, Panama

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

To be included, participants must have:

Open angle glaucoma
IOP-lowering surgical procedure using the CycloPen System

There are no exclusionary criteria.

Treatment and study plan

CycloPen Cyclodialysis System

Device

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.

Primary outcomes

Percent of eyes with intraocular pressure (IOP) reduction ≥ 20% in comparison with baseline

Time frame: 12 months postoperative

Intraocular pressure (IOP) is at least 20% lower than before surgery without additional ocular hypotensive medications or IOP-lowering surgery

Sponsors and collaborators

Lead sponsor

Iantrek, Inc.

Industry

Registry information

Official study 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

Acronym: CREST

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2027
First posted: Aug 18, 2022
Registry last updated: Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting