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

December 21, 2025 updated by: Iantrek, Inc.

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
      • Panama City, Panama
        • CREST Site 301
  • United States
    • California
      • Newport Beach, California, United States, 92663
        • CREST Site 05
    • Florida
      • Cape Coral, Florida, United States, 33904
        • CREST Site 03
      • DeLand, Florida, United States, 32720
        • CREST Site 10
      • Fort Myers, Florida, United States, 33912
        • CREST Site 06
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • CREST Site 07
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • CREST Site 12
      • Rockville, Maryland, United States, 20852
        • CREST Site 13
    • Nevada
      • Las Vegas, Nevada, United States, 89145
        • CREST Site 16
    • New Jersey
      • New Brunswick, New Jersey, United States, 07728
        • CREST Site 14
    • New York
      • New York, New York, United States, 10034
        • CREST Site 15
      • Williamsville, New York, United States, 14221
        • CREST Site 17
    • Pennsylvania
      • Fort Washington, Pennsylvania, United States, 19034
        • CREST Site 01
    • Tennessee
      • Crossville, Tennessee, United States, 38555
        • CREST Site 04
    • Texas
      • Fort Worth, Texas, United States, 76102
        • CREST Site 09
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • CREST Site 11

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Eligible participants who underwent IOP-lowering surgical procedures using the CycloPen Micro-Interventional System for uveoscleral outflow enhancement

Description

To be included, participants must have:

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

There are no exclusionary criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CycloPen Cyclodialysis System in conjunction with cataract surgery
Ophthalmic surgical intervention with the CycloPen Cyclodialysis System in conjunction with cataract surgery
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.
CycloPen Cyclodialysis System in standalone surgery
Ophthalmic surgical intervention with the CycloPen Cyclodialysis System
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iantrek, Inc.

Investigators

  • Study Chair: Tsontcho Ianchulev, MD, Iantrek, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2022

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

August 16, 2022

First Submitted That Met QC Criteria

August 16, 2022

First Posted (Actual)

August 18, 2022

Study Record Updates

Last Update Posted (Estimated)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 21, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITR-CYC-041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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