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

Last updated: December 21, 2025
Sponsor: Iantrek, Inc.
Overall Status: Active - Enrolling

Phase

N/A

Condition

Glaucoma

Open Angle Glaucoma

Treatment

CycloPen Cyclodialysis System

Clinical Study ID

NCT05506423
ITR-CYC-041
  • Ages > 21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: CycloPen Cyclodialysis System
Phase:
Study Start date:
August 17, 2022
Estimated Completion Date:
August 31, 2027

Study 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.

Connect with a study center

  • CREST Site 301

    Ciudad de Panamá,
    Panama

    Site Not Available

  • CREST Site 301

    Panama City 3703443,
    Panama

    Site Not Available

  • CREST Site 05

    Newport Beach, California 92663
    United States

    Site Not Available

  • CREST Site 05

    Newport Beach 5376890, California 5332921 92663
    United States

    Site Not Available

  • CREST Site 03

    Cape Coral, Florida 33904
    United States

    Site Not Available

  • CREST Site 10

    DeLand, Florida 32720
    United States

    Site Not Available

  • CREST Site 06

    Fort Myers, Florida 33901
    United States

    Site Not Available

  • CREST Site 03

    Cape Coral 4149962, Florida 4155751 33904
    United States

    Site Not Available

  • CREST Site 10

    DeLand 4152890, Florida 4155751 32720
    United States

    Site Not Available

  • CREST Site 06

    Fort Myers 4155995, Florida 4155751 33912
    United States

    Site Not Available

  • CREST Site 07

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • CREST Site 07

    Atlanta 4180439, Georgia 4197000 30342
    United States

    Site Not Available

  • CREST Site 12

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • CREST Site 13

    Rockville, Maryland 20852
    United States

    Site Not Available

  • CREST Site 12

    Chevy Chase 4351335, Maryland 4361885 20815
    United States

    Site Not Available

  • CREST Site 13

    Rockville 4367175, Maryland 4361885 20852
    United States

    Site Not Available

  • CREST Site 16

    Las Vegas, Nevada 89145
    United States

    Site Not Available

  • CREST Site 16

    Las Vegas 5506956, Nevada 5509151 89145
    United States

    Site Not Available

  • CREST Site 14

    New Brunswick, New Jersey 07728
    United States

    Site Not Available

  • CREST Site 14

    New Brunswick 5101717, New Jersey 5101760 07728
    United States

    Site Not Available

  • CREST Site 15

    New York, New York 10034
    United States

    Site Not Available

  • CREST Site 15

    New York 5128581, New York 5128638 10034
    United States

    Site Not Available

  • CREST Site 17

    Williamsville 5144588, New York 5128638 14221
    United States

    Site Not Available

  • CREST Site 01

    Fort Washington, Pennsylvania 19034
    United States

    Site Not Available

  • CREST Site 01

    Fort Washington 5190089, Pennsylvania 6254927 19034
    United States

    Site Not Available

  • CREST Site 04

    Crossville, Tennessee 38555
    United States

    Site Not Available

  • CREST Site 04

    Crossville 4616470, Tennessee 4662168 38555
    United States

    Site Not Available

  • CREST Site 09

    Fort Worth, Texas 76102
    United States

    Site Not Available

  • CREST Site 09

    Fort Worth 4691930, Texas 4736286 76102
    United States

    Site Not Available

  • CREST Site 11

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • CREST Site 11

    Salt Lake City 5780993, Utah 5549030 84132
    United States

    Site Not Available

  • CREST Site 02

    Kenosha, Wisconsin 53142
    United States

    Site Not Available

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