An Observational Real-World Evidence Study of Ab-Interno Goniotomy Performed Using the C-Rex Instrument in Patients With Primary Open Angle Glaucoma
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:
• Primary open angle glaucoma
• Goniotomy surgery performed using the C-Rex Instrument
Locations
United States
Georgia
Omni Eye Services
RECRUITING
Atlanta
Tennessee
CIRCLE Site 04
RECRUITING
Crossville
Time Frame
Start Date: 2024-08-14
Estimated Completion Date: 2026-10
Participants
Target number of participants: 200
Treatments
C-Rex surgery - combination
C-Rex surgery combined with cataract extraction/intraocular lens (IOL) implantation
C-Rex surgery - standalone
C-Rex surgery as a standalone intervention
Related Therapeutic Areas
Sponsors
Leads: Iantrek, Inc.