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

Running, not enrolling

Conditions studied: Primary Open Angle Glaucoma (POAG)

In brief

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.

Key facts

Study ID

NCT06615661

Run by

Iantrek, Inc.

People needed

100

Starts

2024-08-14

Expected to finish

2026-12-01

Last updated by the study team

2026-07-21

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• CIRCLE Site 32 — Cape Coral, Florida, United States
• CIRCLE Site 10 — DeLand, Florida, United States
• CIRCLE Site 07 — Atlanta, Georgia, United States
• CIRCLE Site 30 — Brentwood, New York, United States
• CIRCLE Site 31 — Rockville Centre, New York, United States
• CIRCLE Site 04 — Crossville, Tennessee, United States

Full record on ClinicalTrials.gov

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