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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06615661

Acronym

CIRCLE

Enrollment

100

Registered

2024-09-26

Start date

2024-08-14

Completion date

2026-12-01

Last updated

2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Open Angle Glaucoma (POAG)

Keywords

Ocular Hypertension, Eye Diseases, Glaucoma, Goniotomy

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 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.

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. 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.

Interventions

DEVICEC-Rex Instrument

The C-Rex Instrument is a manual ophthalmic surgical instrument used for ab interno goniotomy and inner wall trabeculotomy.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Percent of eyes with intraocular pressure (IOP)reduction ≥20%in comparison with baseline.	12 month postoperative	Intraocular pressure (IOP) is at least 20% lower than before surgery without additional ocular hypotensive medications or IOP-lowering surgery.

Countries

United States

Contacts

STUDY_DIRECTORTsontcho Ianchulev, MD, MPH

CMO

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026