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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-14

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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This a multicenter, observational real-world evidence study of eligible adults with primary open angle glaucoma (POAG) in whom ab-interno goniotomy surgery with the C-Rex Instrument was performed.

Data is collected from the preoperative visit(s) that directly preceded the surgery, the surgical procedure, and post-surgical visits through 12 months postoperatively.

Specific data collected includes C-Rex Instrument goniotomy surgical details, preoperative and postoperative IOP and use of ocular hypotensive medications, and device-related safety events.

Conditions

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Primary Open Angle Glaucoma (POAG)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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C-Rex surgery - combination

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

C-Rex Instrument

Intervention Type DEVICE

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

C-Rex surgery - standalone

C-Rex surgery as a standalone intervention

C-Rex Instrument

Intervention Type DEVICE

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

Interventions

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C-Rex Instrument

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No