Canaloplasty and Trabeculotomy Combined with Phacoemulsification for Glaucoma: 12-Month Results of the GEMINI Study

Mark J Gallardo,1 Mark F Pyfer,2 Steven D Vold,3 Steven R Sarkisian Jr,4 Anita Campbell,5 Inder Paul Singh,6 Brian Flowers,7 Kavita Dhamdhere8 On behalf of the GEMINI study group1El Paso Eye Surgeons, PA, El Paso, TX, USA; 2Northern Ophthalmic Associates, Jenkintown, PA, USA; 3Vold Vision, Fayetteville, AR, USA; 4Oklahoma Eye Surgeons, PLLC, Oklahoma City, OK, USA; 5Grene Vision Group, Wichita, KS, USA; 6Eye Centers of Racine & Kenosha, Racine, WI, USA; 7Ophthalmology Associates, Fort Worth, TX, USA; 8Clinical Development, Sight Sciences, Menlo Park, CA, USACorrespondence: Kavita Dhamdhere, Email kdhamdhere@sightsciences.comPurpose: To report 12-month efficacy outcomes of 360° canaloplasty and 180° trabeculotomy using the OMNI surgical system in combination with phacoemulsification in patients with mild-moderate open-angle glaucoma (OAG) and visually significant cataract.Setting: Fifteen multi-subspecialty ophthalmology practices and surgery centers located in 14 US states.Design: Prospective, multicenter, IRB approved study of patients treated with canaloplasty (360°) and trabeculotomy (180°). Eligible patients had cataract and mild-moderate OAG with intraocular pressure (IOP) ≤ 33 mmHg on 1 to 4 hypotensive medications. Unmedicated post-washout mean diurnal IOP (DIOP) ≥ 21 and ≤ 36 mmHg.Methods: Medication washout preoperatively and prior to month 12 DIOP. Effectiveness outcomes were IOP and IOP lowering medication use. Safety outcomes included adverse events and secondary surgical interventions (SSIs). Evaluations at 1, 3, 6, and 12 months.Results: A total of 149 subjects underwent surgery and 120 were included in the final effectiveness analysis. Mean (standard deviation) unmedicated diurnal IOP was reduced from 23.8 (3.1) mmHg at baseline to 15.6 (4.0) at month 12 (− 35%) and medications (before washout) were reduced from 1.8 (0.9) at baseline to 0.4 (0.9) at month 12 (− 80%). At month 12, 84.2% of eyes achieved IOP reductions > 20% from baseline, 80% of eyes were medication-free, and 76% of eyes achieved IOP between 6– 18 mmHg inclusive. Adverse events were uncommon. Most were mild and self-limited including transient hyphema (9 of 149; 6%) and transient IOP elevations (3 of 149; 2.0%). No eyes required SSIs or experienced loss of VA that was attributable to the device or procedure.Conclusion: Canaloplasty and trabeculotomy performed with the OMNI surgical system at the time of phacoemulsification significantly reduces unmedicated mean diurnal IOP and medication use 12 months postoperatively, with an excellent safety profile. This procedure should be considered for eyes with mild-moderate OAG to reduce IOP, medication burden, or both.Keywords: viscodilation, MIGS, open-angle glaucoma, glaucoma surgery, canaloplasty, trabeculotomy, OMNI