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

NCT05506423 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-12-23

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Iantrek, Inc.

    lead INDUSTRY

Principal Investigators

  • Tsontcho Ianchulev, MD · Iantrek, Inc.

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-17
Primary Completion
2026-08-31
Completion
2027-08-31
FDA Device
Yes

Countries

  • United States
  • Panama

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05506423 on ClinicalTrials.gov