RecruitingNCT06615661

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


Sponsor

Iantrek, Inc.

Enrollment

200 participants

Start Date

Aug 14, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This real-world study collects data on patients with primary open-angle glaucoma (POAG) — the most common type of glaucoma — who have undergone a surgical procedure called goniotomy using a specific instrument called the C-Rex. The goal is to evaluate how well the procedure lowers eye pressure and preserves vision in everyday clinical settings. **You may be eligible if...** - You have been diagnosed with primary open-angle glaucoma (POAG) - You have had goniotomy surgery performed using the C-Rex instrument **You may NOT be eligible if...** - You had any other eye surgery within 8 weeks before your C-Rex procedure - Your eye pressure was higher than 33 mmHg before surgery - You have a type of glaucoma other than POAG - You have other significant eye conditions besides cataract or glaucoma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEC-Rex Instrument

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


Locations(2)

Omni Eye Services

Atlanta, Georgia, United States

CIRCLE Site 04

Crossville, Tennessee, United States

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NCT06615661


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