In a retrospective observational cohort study using data from the American Academy of Ophthalmology IRIS^® Registry, researchers evaluated the effectiveness of standalone canaloplasty and trabeculotomy using the OMNI Surgical System for patients with primary open-angle glaucoma. The findings showed significant and sustained reductions in intraocular pressure and medication use over a 3-year follow-up period.

“The OMNI Surgical System (Sight Sciences, Menlo Park, CA, USA) is a handheld device designed to perform ab interno canaloplasty and trabeculotomy,” described Nathan Radcliffe, MD, of the Mt Sinai School of Medicine in New York, and colleagues in a recent study published in the American Journal of Ophthalmology. They conducted this research to “further characterize the clinical characteristics and outcomes of patients undergoing standalone OMNI surgery” in response to increasing interest in standalone minimally-invasive glaucoma surgery (MIGS) for pseudophakic or precataractous eyes.

Data from 230 eyes of 196 patients with primary open-angle glaucoma (POAG) or ocular hypertension who had documented OMNI procedures between January 2018 and June 2023, as well as a minimum 6-month postoperative follow-up and no prior filtration surgeries, were used in the study. Baseline mean intraocular pressure (IOP) measured 22.1 mmHg. IOP changes were measured at 6, 12, 18, 24, and 36 months, as were glaucoma medication usage and secondary surgical interventions (SSI). Baseline medication usage was 2.1 classes per patient.

With the OMNI procedure, postoperative IOP reductions ranged from 15.1 to 16.7 mmHg across all time points, representing a mean decrease of 5.6 to 7.1 mmHg. Eyes with higher baseline IOP (>18 mmHg) demonstrated greater reductions (7.5 to 8.9 mmHg) compared to eyes with lower baseline IOP (≤18 mmHg, 1.0 to 2.7 mmHg). Reduction in medication use was significant through 18 months. By 36 months, 59.1% of patients were medication-free. These results aligned with previous studies on OMNI’s efficacy.

Overall, 37.4% of eyes required SSI within 36 months. Nearly half (44.4%) of procedures were performed by glaucoma specialists. The remainder were performed by cataract/anterior segment specialists (25.7%) and comprehensive ophthalmologists (13.5%). SSI rates were higher in eyes with elevated baseline IOP (45.9%) than in those with lower baseline IOP (18.3%), perhaps because these eyes were well-controlled with medication and underwent the OMNI procedure to reduce medication burden. The investigators suggested that this data may be valuable in determining future candidates for standalone OMNI. They also noted the diversity of patient characteristics and practice patterns that may also be helpful for other clinicians’s treatment decisions.

The OMNI system demonstrated long-term efficacy in reducing IOP and medication burden for both mild and severe POAG cases. “Of note,” Dr. Radcliffe and colleagues wrote, “the IOP and medication reductions observed in the current study also compare favorably with similar reductions seen with standalone procedures including gonioscopy-assisted transluminal trabeculotomy, trabecular ablation, excisional goniotomy, and ab interno canaloplasty.”

From this and previous data, they concluded that standalone OMNI procedures provide an alternative for patients struggling with medication adherence or side effects.

A full list of author disclosures can be found in the published research.