Observational study of goniotomy surgery for primary open angle glaucoma
An Observational Real-World Evidence Study of Ab-Interno Goniotomy Performed Using the C-Rex Instrument in Patients With Primary Open Angle Glaucoma
This study looks at how well goniotomy surgery works for adults with primary open angle glaucoma and tracks their recovery and any issues for a year after the procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Iantrek, Inc. Industry-sponsored |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT06615661 on ClinicalTrials.gov |
What this trial studies
This observational study enrolls adults diagnosed with primary open angle glaucoma (POAG) who have undergone goniotomy surgery using the C-Rex Instrument. Participants are consented before the surgery and are followed for 12 months postoperatively to collect data on intraocular pressure (IOP), the use of glaucoma medications, and any complications related to the device. The study aims to gather real-world evidence regarding the effectiveness and safety of this surgical approach in managing POAG.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with a diagnosis of primary open angle glaucoma who are scheduled to undergo goniotomy surgery with the C-Rex Instrument.
Not a fit: Patients with a history of intraocular surgery within 8 weeks prior to the C-Rex surgery or those with preoperative IOP higher than 33 mmHg may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of goniotomy surgery in lowering IOP for patients with primary open angle glaucoma.
How similar studies have performed: Other studies have shown success with similar surgical approaches for managing glaucoma, indicating potential for positive outcomes in this study.
Eligibility criteria
Show full inclusion / exclusion 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 clinically significant intraocular pathology other than cataract or glaucoma
Where this trial is running
Atlanta, Georgia and 1 other locations
- Omni Eye Services — Atlanta, Georgia, United States (Recruiting)
- CIRCLE Site 04 — Crossville, Tennessee, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.