NCT05506423

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

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Iantrek, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Open Angle Glaucoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-17
• Primary completion: 2026-08-01
• Completion: 2027-08-01
• First posted: 2022-08-18
• Last updated: 2025-12-23

Locations

16 sites across 2 countries: United States, Panama

Regulatory

• FDA-regulated device study