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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Primary Open Angle Glaucoma (POAG) Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CIRCLE Site 32, Cape Coral, Florida, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

C-Rex Instrument

Device

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

Primary outcomes

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

Time frame: 12 month postoperative

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

Sponsors and collaborators

Lead sponsor

Iantrek, Inc.

Industry

Registry information

Official study title

An Observational Real-World Evidence Study of Ab-Interno Goniotomy Performed Using the C-Rex Instrument in Patients With Primary Open Angle Glaucoma

Acronym: CIRCLE

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Sep 26, 2024
Registry last updated: Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed