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

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 design

Treatments tested in this trial

  • C-Rex Instrument

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators