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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Iantrek, Inc.
Study ID
NCT06615661
Status
Recruiting
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Conditions

  • Primary Open Angle Glaucoma (POAG)

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 14, 2024
Status verified
Mar 2025
Primary completion
Sep 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: C-Rex surgery - combination
    C-Rex surgery combined with cataract extraction/intraocular lens (IOL) implantation
  • Arm: C-Rex surgery - standalone
    C-Rex surgery as a standalone intervention

Primary Outcome Measure

Percent of eyes with intraocular pressure (IOP)reduction ≥20%in comparison with baseline. [ Time Frame: 12 month postoperative ]

Locations (2)

FacilityCityStateZIPSite coordinators
Omni Eye ServicesAtlantaGeorgia30342
Study Coordinator
[email protected]
404-257-0814
CIRCLE Site 04CrossvilleTennessee38555
Site 04 Study Coordinator
[email protected]
931-265-5879

Find similar trials in Atlanta, GA

By research site
Omni Eye Services· Atlanta, GACIRCLE· Crossville, TN

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