The American Journal of Ophthalmology recently published a real-world, 36-month analysis confirming the long-term effectiveness of the OMNI® Surgical System (OMNI) by Sight Sciences (California, USA) in managing primary open-angle glaucoma (POAG).
The study, based on real-world data from the American Academy of Ophthalmology’s IRIS® (Intelligent Research in Sight) Registry, is the largest to date evaluating standalone canaloplasty and trabeculotomy. It revealed sustained reductions in intraocular pressure (IOP) and decreased reliance on medications for up to 36 months post-OMNI-surgery.1
“This analysis represents one of the most comprehensive, real-world evaluations of standalone canaloplasty and trabeculotomy,” said lead investigator Dr. Nathan M. Radcliffe in a news release. “Our findings underscore the ability of OMNI to achieve significant and sustained reductions in IOP and medication use over three years.”
The retrospective, observational cohort study examined patients with POAG or ocular hypertension. Subjects included those with known laterality who underwent standalone canaloplasty and trabeculotomy using OMNI between January 1, 2016 and June 30, 2024. Eligible patients required at least six months and up to 36 months of postoperative follow-up.1
Exclusions were made for eyes with prior filtration surgery, trabeculoplasty within 90 days of the OMNI procedure, or those undergoing concomitant cataract surgery. In total, the study evaluated 230 eyes from 196 patients.1
Here are the study’s key findings:
- Sustained IOP reduction: Mean baseline IOP of 22.1 mmHg was reduced to between 15.1 and 16.7 mmHg over 36 months, with reductions ranging from 5.6 to 7.1 mmHg (p<0.0001).
- Greater reductions for high IOP patients: Patients with baseline IOP over 18 mmHg saw reductions of up to 8.9 mmHg.
- Reduced medication use: Medication dependence decreased significantly, with the average number of medications reduced from 2.1 at baseline to 1.1-1.6 through 36 months.1
Sight Sciences CEO Paul Badawi emphasized the significance of these findings, stating, “This study further strengthens the extensive body of clinical data supporting OMNI’s safety and efficacy. It reinforces our commitment to delivering innovative, data-driven interventional technologies that empower physicians to elevate patient care.”
The OMNI Surgical System is a versatile device designed to perform two sequential procedures—canaloplasty and trabeculotomy—using a single device. By addressing all three potential points of aqueous outflow resistance—trabecular meshwork, Schlemm’s canal and collector channels—OMNI works to lower IOP effectively without needing implants, reducing risks and offering a durable solution for glaucoma management.
References
- Radcliffe NM, Harris J, Garcia K, et al. Standalone canaloplasty and trabeculotomy using the OMNI Surgical System in eyes with primary open-angle glaucoma: A 36-month analysis from the American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight): Standalone outcomes of canaloplasty and trabeculotomy. Am J Ophthalmol. 2024:S0002-9394(24)00581-6.
