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This study enrolls adults with primary open angle glaucoma (POAG) who underwent goniotomy intraocular pressure (IOP)-lowering surgery with the C-Rex Instrument. Patients are consented prior to surgery and followed for 12 months postoperatively. Data regarding IOP, use of glaucoma medications, and any device-related complications are collected during the study time period.
This a multicenter, observational real-world evidence study of eligible adults with primary open angle glaucoma (POAG) in whom ab-interno goniotomy surgery with the C-Rex Instrument was performed.
Data is collected from the preoperative visit(s) that directly preceded the surgery, the surgical procedure, and post-surgical visits through 12 months postoperatively.
Specific data collected includes C-Rex Instrument goniotomy surgical details, preoperative and postoperative IOP and use of ocular hypotensive medications, and device-related safety events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C-Rex surgery - combination | C-Rex surgery combined with cataract extraction/intraocular lens (IOL) implantation |
| |
| C-Rex surgery - standalone | C-Rex surgery as a standalone intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C-Rex Instrument | Device | The C-Rex Instrument is a manual ophthalmic surgical instrument used for ab interno goniotomy and inner wall trabeculotomy. |
|
| 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 month postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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Eligible participants who underwent IOP-lowering surgical procedures using the C-Rex Instrument to perform ab-interno goniotomy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Omni Eye Services | Recruiting | Atlanta | Georgia | 30342 | United States |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D005901 | Glaucoma |
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| CIRCLE Site 04 | Recruiting | Crossville | Tennessee | 38555 | United States |
|