Canaloplasty and Trabeculotomy Combined with Phacoemulsification in Open-Angle Glaucoma: Interim Results from the GEMINI Study

Purpose: To report interim 6-month safety and efficacy outcomes of 360 degrees canaloplasty and 180 degrees trabeculotomy using the OMNI (R) Surgical System concomitantly with phacoemulsification in patients with open-angle glaucoma (OAG). Setting: Fifteen multi-subspecialty ophthalmology practices and surgery centers located in 14 states (Alabama, Arizona, Arkansas, Florida, Georgia, Iowa, Kansas, Montana, Nebraska, North Dakota, Oklahoma, Pennsylvania, Texas, and Wisconsin). Design: Prospective, multicenter, IRB approved study of patients treated with canaloplasty (360 degrees) and trabeculotomy (180 degrees). Eligible patients had cataract and mild-moderate OAG with intraocular pressure (IOP) <= 33 mmHg on 1 to 4 hypotensive medications. Methods: Medication washout prior to baseline diurnal IOP (Goldmann). Effectiveness outcomes included mean IOP and medications. Safety outcomes included adverse events (AE), best corrected visual acuity (BCVA) and secondary surgical interventions (SSI). Analysis includes descriptive statistics and t-tests evaluating change from baseline. Results: A total of 137 patients were enrolled and treated. Mean diurnal IOP after washout was 23.8 +/- 3.1 mmHg at baseline. At month 6, 78% (104/134) were medication free with IOP of 14.2 mmHg, a mean reduction of 9.0 mmHg (38%). 100% (104/104) had a >= 20% reduction in IOP and 86% (89/104) had IOP >= 6 and <= 18 mmHg. The mean number of medications at screening was 1.8 +/- 0.9 and 0.6 +/- 1.0 at month 6. AE included transient hyphema (4.6%) and IOP elevation >= 10 mmHg (2%). There were no AE for loss of BCVA or recurring hyphema. There were no SSI. Conclusion: Canaloplasty followed with trabeculotomy and performed concomitantly with phacoemulsification has favorable intra and perioperative safety, significantly reduces IOP and anti-glaucoma medications through 6 months in eyes with mild-moderate OAG.