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A Real-World Evidence Study of Goniotomy With the C-REX™ Instrument in Patients With Primary Open Angle Glaucoma
NCT06615661 · Iantrek, Inc.
In plain English
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Official title
An Observational Real-World Evidence Study of Ab-Interno Goniotomy Performed Using the C-Rex Instrument in Patients With Primary Open Angle Glaucoma
About this study
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.
Eligibility criteria
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
Enrollment target: 200 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-08-14
Estimated completion: 2026-10
Last updated: 2025-03-20
Interventions
Device: C-Rex Instrument
Primary outcomes
- • Percent of eyes with intraocular pressure (IOP)reduction ≥20%in comparison with baseline. (12 month postoperative)
Sponsor
Iantrek, Inc. · industry
All locations (2)
Omni Eye ServicesRecruiting
Atlanta, Georgia, United States
CIRCLE Site 04Recruiting
Crossville, Tennessee, United States