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NCT05506423 Clinical Trial

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

Open Angle Glaucoma Clinical Trial

— CREST  

Official 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05506423
Other study ID # ITR-CYC-041
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date August 17, 2022
Est. completion date March 2026

Study information
Verified date January 2024
Source Iantrek, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 300
Est. completion date March 2026
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States CREST Site 07 Atlanta Georgia
United States CREST Site 03 Cape Coral Florida
United States CREST Site 04 Crossville Tennessee
United States CREST Site 10 DeLand Florida
United States CREST Site 06 Fort Myers Florida
United States CREST Site 01 Fort Washington Pennsylvania
United States CREST Site 02 Kenosha Wisconsin
United States CREST Site 05 Newport Beach California
United States CREST Site 11 Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
Iantrek, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent of eyes with intraocular pressure (IOP) reduction = 20% in comparison with baseline Intraocular pressure (IOP) is at least 20% lower than before surgery without additional ocular hypotensive medications or IOP-lowering surgery 12 months postoperative
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