Real World Evaluation Of Canaloplasty And Trabeculotomy Combined With Cataract Surgery In Open-Angle Glaucoma (Oag): A Retrospective, Multicenter, 12-Month Study ( Romeo Ii)

The goal of glaucoma surgery is to promote egress of aqueous humor restoring intraocular pressure (IOP) to a level in harmony with optic nerve health. Ab interno 360 degree canaloplasty with trabeculotomy (OMNI® Surgical System, Sight Sciences, Menlo Park, CA, USA) combined with phacoemulsification cataract surgery addresses multiple points of resistance to outflow in the conventional outflow pathway (i.e., juxtacanalicular trabecular meshwork, Schlemm’s canal, collector channels). The aim of this study was to report the clinical experience of 17 surgeons with 12-month effectiveness and safety outcomes for patients treated with the OMNI device in combination with phacoemulsification cataract surgery.

This was a multicenter retrospective, observational, consecutive study of all eyes meeting eligibility criteria and treated with the OMNI system at the time of cataract surgery from 14 multi-subspecialty ophthalmic practices in 10 US states (AL, AR, CA, CT, KS, LA, MO, NY, SD, TN). All surgeries took place between March 14, 2018 and November 2, 2020. The IRB approved the study and waived the requirement for informed consent due to the retrospective non-interventional study design.

Seventeen surgeons contributed 76 patients meeting eligibility criteria: mild to moderate OAG (visual field mean deviation (MD) not worse than -12 dB), 12-month follow-up, preoperative medicated IOP >18 mmHg and ≤36 mmHg on ≤ 5 medications, visually significant cataract. One eye per patient enrolled. Endpoints included mean IOP, change in IOP, ocular hypotensive medication use, and proportion of patients with a 20% or greater reduction in IOP at 12 months. Safety included best corrected visual acuity (BCVA) and adverse events (AE). Paired t-tests were used for comparison of pre-operative IOP and medications with status at follow-up time points.

76 patients were included. Average age (SD) was 73.2 (8.1), most were White (79%), had a diagnosis of primary OAG (71%), mean MD of -4.4 (3.8) dB. 40 males, 36 females. Mean preoperative IOP was 22.0 (3.5) mmHg on 1.9 (1.3) medications. IOP was 15.6 (3.3) at Month 1 and 15.1 (3.4) at Month 12 (p<<.0001) on 1.6 (Month 1) to 1.1 (Month 12) (p<<.0001) medications; reductions at Month 12 of 7.1 mmHg (-32.3%) and 0.8 medications (-43%). 75% of patients had a ≥20% reduction in IOP, 34% (versus 12%, preoperatively) were medication free. Adverse events were generally self-resolving and non-serious including hyphema >1 mm (3, 4%), iridodialysis, corneal edema, guttata, and BCVA decrease, all 1.3%. There was one secondary surgical intervention.

Elevated IOP is the most important and only treatable risk factor for glaucoma. Elevated IOP results from abnormal resistance to outflow which may reside in the trabecular meshwork, Schlemm’s canal or collector channels. The OMNI addresses resistance in all three by combining circumferential canaloplasty and trabeculotomy. In this cohort of 76 patients, OMNI combined with cataract surgery, provided effective IOP-lowering durable through 12 months. Safety was consistent with previous studies of the OMNI and, importantly, there were few adverse events related to the procedure and none that were serious. The OMNI was shown to be a safe and effective MIGS in combination with cataract surgery.