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

NCT06615661 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-03-20

No results posted yet for this 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.

Conditions

  • Primary Open Angle Glaucoma (POAG)

Interventions

DEVICE

C-Rex Instrument

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

Sponsors & Collaborators

  • Iantrek, Inc.

    lead INDUSTRY

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-14
Primary Completion
2026-09-30
Completion
2026-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06615661 on ClinicalTrials.gov