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

NCT06615661 | Recruiting FDA Device

• 1 other identifier: ITR-GON-041
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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)

Keywords

Ocular Hypertension; Eye Diseases; Glaucoma; Goniotomy

Outcome Measures

Primary Outcomes (1)

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

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

  12 month postoperative

Study Arms (2)

C-Rex surgery - combination

C-Rex surgery combined with cataract extraction/intraocular lens (IOL) implantation

Device: C-Rex Instrument

C-Rex surgery - standalone

C-Rex surgery as a standalone intervention

Device: C-Rex Instrument

Interventions

C-Rex Instrument DEVICE

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

C-Rex surgery - combination; C-Rex surgery - standalone

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible participants who underwent IOP-lowering surgical procedures using the C-Rex Instrument to perform ab-interno goniotomy

You may qualify if:

• Primary open angle glaucoma
• Goniotomy surgery performed using the C-Rex Instrument

You may not qualify if:

• 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

Sponsors & Collaborators

• Iantrek, Inc.: lead

Study Sites (2)

Omni Eye Services

Atlanta, Georgia, 30342, United States

RECRUITING

CIRCLE Site 04

Crossville, Tennessee, 38555, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Eye Diseases; Glaucoma

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 26, 2024
• Study Start: August 14, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)