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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
C-Rex Instrument
DeviceThe C-Rex Instrument is a manual ophthalmic surgical instrument used for ab interno goniotomy and inner wall trabeculotomy.
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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