NCT06615661

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Iantrek, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Primary Open Angle Glaucoma (POAG)

Interventions

Type	Name	Description
DEVICE	C-Rex Instrument	The C-Rex Instrument is a manual ophthalmic surgical instrument used for ab interno goniotomy and inner wall trabeculotomy.

Timeline

• Start date: 2024-08-14
• Primary completion: 2026-09-01
• Completion: 2026-10-01
• First posted: 2024-09-26
• Last updated: 2025-03-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study