Actively Recruiting
An Observational Real-World Evidence Study of Ab-Interno Goniotomy Performed Using the C-Rex Instrument in Patients With Primary Open Angle Glaucoma
Led by Iantrek, Inc. · Updated on 2025-03-20
200
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating adults with primary open angle glaucoma (POAG) who have undergone goniotomy surgery using the C-Rex Instrument. This observational real-world evidence study focuses on understanding surgical outcomes, including changes in intraocular pressure (IOP), medication use, and any complications related to the device. The study is conducted at multiple centers and follows patients who had this specific IOP-lowering surgery. Participants receive ab interno goniotomy surgery with the C-Rex Instrument either combined with cataract extraction and intraocular lens implantation or as a standalone procedure. Data collection includes details from the preoperative visit before surgery, the surgical procedure itself, and follow-up visits up to 12 months after surgery. This allows for monitoring of surgical effects and device-related safety. During the 12-month follow-up, researchers gather information on IOP levels compared to baseline, use of glaucoma medications, and any device-related complications. The main outcome measured is the percentage of eyes showing at least a 20% reduction in IOP at 12 months after surgery. This ongoing monitoring helps assess the surgical procedure's impact and safety over time.
CONDITIONS
Brief Title
A Real-World Evidence Study of Goniotomy With the C-REX™ Instrument in Patients With Primary Open Angle Glaucoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary open angle glaucoma
- Goniotomy surgery performed using the C-Rex Instrument
- Adults aged 22 years or older
You will not qualify if you...
- History of intraocular surgery within 8 weeks prior to C-Rex surgery
- Preoperative intraocular pressure higher than 33 mmHg
- Presence of a glaucoma type other than primary open angle glaucoma
- Presence of clinically significant intraocular pathology other than cataract or glaucoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 week before surgery
Participants undergo preoperative assessments before the goniotomy surgery.
1 preoperative visit (in-person)
Duration - Day of surgery
Participants undergo ab-interno goniotomy surgery using the C-Rex Instrument, either standalone or combined with cataract extraction/IOL implantation.
1 surgical visit (in-person)
Duration - Up to 12 months postoperatively
Participants are observed with post-surgical visits to monitor intraocular pressure, medication use, and device-related safety events.
Multiple follow-up visits through 12 months post-surgery
Trial Site Locations
Total: 2 locations
1
Omni Eye Services
Atlanta, Georgia, United States, 30342
Actively Recruiting
2
CIRCLE Site 04
Crossville, Tennessee, United States, 38555
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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