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

Last updated: January 22, 2024
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:
March 31, 2026

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 05

    Newport Beach, California 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 33912
    United States

    Site Not Available

  • CREST Site 07

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • CREST Site 01

    Fort Washington, Pennsylvania 19034
    United States

    Site Not Available

  • CREST Site 04

    Crossville, Tennessee 38555
    United States

    Site Not Available

  • CREST Site 11

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • CREST Site 02

    Kenosha, Wisconsin 53142
    United States

    Site Not Available

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