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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: 100 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-08-14
Estimated completion: 2026-12
Last updated: 2026-07-21
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
Contacts & investigators
InvestigatorTsontcho Ianchulev, MD, MPH · study_director, CMO
All locations (6)
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