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

NCT06615661 · tracked via the Priya Life Science USA tracker

Sponsor

Iantrek, Inc.

Phase

Observational

Started

2024-08-14

Last updated

2026-07-21

Condition(s) studied

Primary Open Angle Glaucoma (POAG)

Investigational drug(s) / intervention(s)

C-Rex Instrument

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

Study 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

Sex

ALL

Min age

22 Years

Max age

—

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

Primary outcome measure(s)

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.

Trial sites (6)

Facility	City	Region
CIRCLE Site 32	Cape Coral	Florida
CIRCLE Site 10	DeLand	Florida
CIRCLE Site 07	Atlanta	Georgia
CIRCLE Site 30	Brentwood	New York
CIRCLE Site 31	Rockville Centre	New York
CIRCLE Site 04	Crossville	Tennessee

More Iantrek, Inc. trials in the USA

Study of the CycloPen Micro-Interventional System and Long-Term Clinical Outcomes Active, not recruiting

A Study of Outcomes Following Bio-Reinforced Canaloplasty in Eyes With Open-Angle Glaucoma Enrolling by invitation

5-Year Postoperative Outcomes of Patients Who Completed the CREST Study Enrolling by invitation

Other trials for the same condition

Direct Selective Laser Trabeculoplasty (DSLT) for Reducing Eye Pressure in Non-Caucasian Patients With Open Angle Glaucoma Recruiting

A Study to Evaluate Efficacy and Safety of YSBP Compared to Lumigan in Patients With Glaucoma or Ocular Hypertension Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06615661 on ClinicalTrials.gov ↗ ← All trials in the USA