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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorIantrek, Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Primary open angle glaucoma

Goniotomy surgery performed using the C-Rex Instrument

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • C-Rex Instrument

    Device

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: C-Rex surgery - combination1 intervention
Group B: C-Rex surgery - standalone1 intervention

Trial outcomes

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.

Time frame
12 month postoperative

Secondary outcomes

Other outcomes

Sponsors and contacts

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