An Observational Real-World Evidence Study of Ab-Interno Goniotomy Performed Using the C-Rex Instrument in Patients With Primary Open Angle Glaucoma

What this Trial Is About

Researchers are evaluating adults with primary open angle glaucoma POAG who have undergone goniotomy surgery using the C-Rex Instrument. This observational real-world evidence study focuses on understanding surgical outcomes, including changes in intraocular pressure IOP, medication use, and any complications related to the device. The study is conducted at multiple centers and follows patients who had this specific IOP-lowering surgery. Participants receive ab interno goniotomy surgery with the C-Rex Instrument either combined with cataract extraction and intraocular lens implantation or as a standalone procedure. Data collection includes details from the preoperative visit before surgery, the surgical procedure itself, and follow-up visits up to 12 months after surgery. This allows for monitoring of surgical effects and device-related safety. During the 12-month follow-up, researchers gather information on IOP levels compared to baseline, use of glaucoma medications, and any device-related complications. The main outcome measured is the percentage of eyes showing at least a 20 reduction in IOP at 12 months after surgery. This ongoing monitoring helps assess the surgical procedures impact and safety over time.

A Real-World Evidence Study of Goniotomy With the C-REX™ Instrument in Patients With Primary Open Angle Glaucoma