A Real-World Evidence Study of Goniotomy With the C-REX™ Instrument in Patients With Primary Open Angle Glaucoma (CIRCLE)

Iantrek

Status

Enrolling

Conditions

Primary Open Angle Glaucoma (POAG)

Treatments

Device: C-Rex Instrument

Study type

Observational

Funder types

Industry

Identifiers

NCT06615661

ITR-GON-041

Details and patient eligibility

About

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.

Full 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.

Data is collected from the preoperative visit(s) that directly preceded the surgery, the surgical procedure, and post-surgical visits through 12 months postoperatively.

Specific data collected includes C-Rex Instrument goniotomy surgical details, preoperative and postoperative IOP and use of ocular hypotensive medications, and device-related safety events.

Enrollment

200 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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