Multicenter Glaucoma Study Investigating Standalone Canaloplasty
A multicenter, randomized, clinical trial to evaluate the efficacy of canaloplasty performed as a standalone procedure using the iTrack™ Advance canaloplasty device (Nova Eye, Inc.) as compared to the OMNI® Surgical System (Sight Sciences) in patients with mild to moderate primary open-angle glaucoma.
| Condition(s) | Primary Open Angle Glaucoma |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | A multicenter, randomized, clinical trial to evaluate the efficacy of canaloplasty performed as a standalone procedure using the iTrack™ Advance canaloplasty device (Nova Eye, Inc.) as compared to the OMNI® Surgical System (Sight Sciences) in patients with mild to moderate primary open-angle glaucoma. |
| Who can participate | Inclusion Criteria: * Male or female subjects, 22 years or older at the time of surgery * Diagnosed with mild to moderate primary open angle glaucoma * Candidate for canaloplasty surgery: i.e., catheterization of Schlemm's canal and subsequent viscodilation of Schlemm's canal, without trabeculotomy * Intolerance to medical therapy OR need/willingness to reduce medications * At the Screening Visit, IOP of ≤ 30 mmHg while on 1-4 ocular hypotensive medications * At the Baseline Visit, unmedicated IOP ≥ 21mmHg and ≤ 36 mmHg, and ≥ 3mmHg higher than medicated IOP * Shaffer grade of ≥ 3 in all four quadrants * Central corneal thickness ≥ 480µm and ≤ 620 µm * Able and willing to comply with the study procedures and attend all follow-up visits * Understands and signs the informed consent Exclusion |
| Ages | 22 Years |
| Sex | All |
| Lead sponsor | Nova Eye, Inc. |
| Locations | Düsseldorf, Germany; Madrid, Spain; Edinburgh, United Kingdom; Liverpool, United Kingdom; Manchester, United Kingdom |
| Start date | 2023-05-09 |
| NCT ID | NCT05786196 |
| Official listing | https://clinicaltrials.gov/study/NCT05786196 |