Status:
RECRUITING
A Real-World Evidence Study of Goniotomy With the C-REX™ Instrument in Patients With Primary Open Angle Glaucoma
Lead Sponsor:
Iantrek, Inc.
Conditions:
Primary Open Angle Glaucoma (POAG)
Eligibility:
All Genders
22+ years
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...
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. Da...
Eligibility Criteria
Inclusion
- Primary open angle glaucoma
- Goniotomy surgery performed using the C-Rex Instrument
Exclusion
- 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
Key Trial Info
Start Date :
August 14 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06615661
Start Date
August 14 2024
End Date
October 1 2026
Last Update
March 20 2025
Active Locations (2)
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1
Omni Eye Services
Atlanta, Georgia, United States, 30342
2
CIRCLE Site 04
Crossville, Tennessee, United States, 38555