A Real-World Evidence Study of Goniotomy With the C-REX™ Instrument in Patients With Primary Open Angle Glaucoma
Recruiting
Observational Study
Primary Open Angle Glaucoma (POAG)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
22 and older
Sex
Any
Study type
Observational
Participants needed
200 (estimated)
Sponsor
Iantrek, Inc. · Industry
Who this trial is looking for
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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.
Trial Locations
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Status
Eligibility Criteria
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 …
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
Contacts
No contact information available.
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