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NCT06615661
A Real-World Evidence Study of Goniotomy With the C-REX™ Instrument in Patients With Primary Open Angle Glaucoma
Conditions: Primary Open Angle Glaucoma (POAG)
Sex: All
Ages: 22 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: Iantrek, Inc.
Location: CIRCLE Site 32 Cape Coral Florida
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 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
Source: ClinicalTrials.gov (NCT06615661). StuddyBuddy aggregates publicly available trial information.