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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CycloPen Cyclodialysis System in conjunction with cataract surgery | Ophthalmic surgical intervention with the CycloPen Cyclodialysis System in conjunction with cataract surgery |
| |
| CycloPen Cyclodialysis System in standalone surgery | Ophthalmic surgical intervention with the CycloPen Cyclodialysis System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CycloPen Cyclodialysis System | Device | 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. |
| 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 |
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To be included, participants must have:
There are no exclusionary criteria.
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Eligible participants who underwent IOP-lowering surgical procedures using the CycloPen Micro-Interventional System for uveoscleral outflow enhancement
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| Name | Affiliation | Role |
|---|---|---|
| Tsontcho Ianchulev, MD | Iantrek, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CREST Site 05 | Newport Beach | California | 92663 | United States | ||
| CREST Site 03 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40799662 | Derived | Barber K, Flowers B, Patterson M, Vera L, Ianchulev T, Ahmed II. Bio-interventional uveoscleral outflow enhancement in patients with medically uncontrolled primary open-angle glaucoma: 1-year results of allograft-reinforced cyclodialysis. Ther Adv Ophthalmol. 2025 Aug 11;17:25158414251362010. doi: 10.1177/25158414251362010. eCollection 2025 Jan-Dec. |
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| Cape Coral |
| Florida |
| 33904 |
| United States |
| CREST Site 10 | DeLand | Florida | 32720 | United States |
| CREST Site 06 | Fort Myers | Florida | 33912 | United States |
| CREST Site 07 | Atlanta | Georgia | 30342 | United States |
| CREST Site 12 | Chevy Chase | Maryland | 20815 | United States |
| CREST Site 13 | Rockville | Maryland | 20852 | United States |
| CREST Site 16 | Las Vegas | Nevada | 89145 | United States |
| CREST Site 14 | New Brunswick | New Jersey | 07728 | United States |
| CREST Site 15 | New York | New York | 10034 | United States |
| CREST Site 17 | Williamsville | New York | 14221 | United States |
| CREST Site 01 | Fort Washington | Pennsylvania | 19034 | United States |
| CREST Site 04 | Crossville | Tennessee | 38555 | United States |
| CREST Site 09 | Fort Worth | Texas | 76102 | United States |
| CREST Site 11 | Salt Lake City | Utah | 84132 | United States |
| CREST Site 301 | Panama City | Panama |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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