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

Recruiting

• Conditions: Primary Open Angle Glaucoma (POAG)
• Interventions: Device: C-Rex Instrument

• Registration Number: NCT06615661
• Lead Sponsor: Iantrek, Inc.

Brief 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.

Study Timeline

• Study Start: 2024-08-14
• Study First Submitted: 2024-09-24
• Study First Submitted QC: 2024-09-24
• Study First Posted: 2024-09-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-20
• Primary Completion: 2026-09
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Primary open angle glaucoma
• Goniotomy surgery performed using the C-Rex Instrument

Exclusion Criteria

• History of intraocular surgery within 8 weeks prior to C-Rex surgery
• Preoperative IOP higher than 33 mmHg
• Presence of a glaucoma type other than POAG
• Presence of clinically significant intraocular pathology other than cataract or glaucoma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
C-Rex surgery - combination	C-Rex Instrument	C-Rex surgery combined with cataract extraction/intraocular lens (IOL) implantation
C-Rex surgery - standalone	C-Rex Instrument	C-Rex surgery as a standalone intervention

Primary Outcome Measures

Name	Time	Method
Percent of eyes with intraocular pressure (IOP)reduction ≥20%in comparison with baseline.	12 month postoperative	Intraocular pressure (IOP) is at least 20% lower than before surgery without additional ocular hypotensive medications or IOP-lowering surgery.

Trial Locations

Locations (2)

Omni Eye Services; 🇺🇸 Atlanta, Georgia, United States

CIRCLE Site 04; 🇺🇸 Crossville, Tennessee, United States