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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Open Angle Glaucoma

Intervention / Treatment
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* Device: CycloPen Cyclodialysis System


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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CycloPen - Combination Surgery<br>Ophthalmic surgical intervention with the CycloPen Cyclodialysis System in conjunction with cataract surgery | Device: CycloPen Cyclodialysis System<br>* The CycloPen Micro-Interventional Cyclodialysis System is a manual surgical instrument for ab-interno supraciliary intervention to enhance uveoscleral outflow. The CycloPen may be used to deliver allograft tissue and/or viscous material to reinforce and maintain the cyclodialysis cleft.<br>|
| CycloPen - Standalone Surgery<br>Standalone ophthalmic surgical intervention with the CycloPen Cyclodialysis System | Device: CycloPen Cyclodialysis System<br>* The CycloPen Micro-Interventional Cyclodialysis System is a manual surgical instrument for ab-interno supraciliary intervention to enhance uveoscleral outflow. The CycloPen may be used to deliver allograft tissue and/or viscous material to reinforce and maintain the cyclodialysis cleft.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |