A Real-World Evidence Study of Goniotomy With the C-REX™ Instrument in Patients With Primary Open Angle Glaucoma
An Observational Real-World Evidence Study of Ab-Interno Goniotomy Performed Using the C-Rex Instrument in Patients With Primary Open Angle Glaucoma
Iantrek, Inc.
200 participants
Aug 14, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria2
- Primary open angle glaucoma
- Goniotomy surgery performed using the C-Rex Instrument
Exclusion Criteria4
- 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
Interventions
The C-Rex Instrument is a manual ophthalmic surgical instrument used for ab interno goniotomy and inner wall trabeculotomy.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06615661