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A Real-World Evidence Study of Goniotomy With the C-REX™ Instrument in Patients With Primary Open Angle Glaucoma
Sponsor: Iantrek, Inc.
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.
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
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2024-08-14
Completion Date
2026-12
Last Updated
2026-07-21
Healthy Volunteers
No
Conditions
Interventions
C-Rex Instrument
The C-Rex Instrument is a manual ophthalmic surgical instrument used for ab interno goniotomy and inner wall trabeculotomy.
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