Multicenter Glaucoma Study Investigating Standalone Canaloplasty, Randomized Controlled Trial: iTrack Advance (Nova Eye, Inc.) Compared to OMNI (Sight Sciences)
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.
• 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