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

Conditions

Open Angle Glaucoma

Brief 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.

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.

Reiss G, Francis B, Nguyen Q, Garg R, Ianchulev T, Sieminski S, Singh P.

2026-06-26

10.1371/journal.pone.0351552

Standalone Bio-Interventional Uveoscleral Outflow Enhancement for Intraocular Pressure Reduction in Open-Angle Glaucoma: One-Year Results from a Prospective Multicenter Real-World Evidence Study (NCT05506423)

George R. Reiss, Brian A. Francis, Quang H. Nguyen, Reena Garg, Tsontcho Ianchulev et al. (7 authors)

2025-12-15

10.64898/2025.12.11.25342101

Bio-interventional uveoscleral outflow enhancement in patients with medically uncontrolled primary open-angle glaucoma: 1-year results of allograft-reinforced cyclodialysis

Kenneth Barber, Brian Flowers, Michael Patterson, Lautaro Vera, Tsontcho Ianchulev et al. (6 authors)

Therapeutic Advances in Ophthalmology2025-07-01

10.1177/25158414251362010

Interventions

DEVICECycloPen Cyclodialysis System

The CycloPen Micro-Interventional Cyclodialysis System is used to create a cyclodialysis cleft and deliver allograft scleral tissue and/or viscous material within the cleft for endoscleral reinforcement.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

No

Inclusion criteria

To be included, participants must have: 1. Open angle glaucoma 2. IOP-lowering surgical procedure using the CycloPen System There are no exclusionary criteria.

Design outcomes

Primary

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

Countries

Panama, United States

Contacts

STUDY_CHAIRTsontcho Ianchulev, MD,MPH

Iantrek, Inc.

Outcome results

None listed