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

Iantrek, Inc.200 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Primary Open Angle Glaucoma (POAG)

Interventions

C-Rex InstrumentDEVICE

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

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (2)

Omni Eye Services

Atlanta, Georgia, United States

RECRUITING

CIRCLE Site 04

Crossville, Tennessee, United States

RECRUITING

Outcomes

Primary Outcomes

Percent of eyes with intraocular pressure (IOP)reduction ≥20%in comparison with baseline.

Intraocular pressure (IOP) is at least 20% lower than before surgery without additional ocular hypotensive medications or IOP-lowering surgery.

Time frame: 12 month postoperative

Data from ClinicalTrials.gov

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