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

N/AActive Not RecruitingNCT05506423

Iantrek, Inc.300 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Open Angle Glaucoma

Interventions

CycloPen Cyclodialysis SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (16)

Visionary Eye Institute

Newport Beach, California, United States

Tyson Eye

Cape Coral, Florida, United States

Outcomes

Primary Outcomes

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

Time frame: 12 months postoperative

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.