Extended follow-up shows durable IOP control with Omni surgical system
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MARCO ISLAND, Fla. — Two-year follow-up of the ROMEO study showed efficacy of the Omni surgical system in reducing IOP and medication use over the long term in patients with primary open-angle glaucoma.
The 2-year data were presented in a poster by Anita Campbell, MD, and colleagues at the Women in Ophthalmology Summer Symposium.
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ROMEO was the first multicenter study evaluating circumferential canaloplasty plus trabeculotomy using the Omni surgical system (Sight Sciences) and provided the basis for FDA clearance. The 2-year extension included 65% of ROMEO subjects treated in seven of the 11 original sites, for a total of 72 patients stratified according to preoperative IOP greater than 18 mm Hg (group 1) and 18 mm Hg or less (group 2).
Canaloplasty plus trabeculotomy was performed in combination with cataract surgery or as a stand-alone procedure.
In group 1, mean IOP at the last follow-up visit was 15.6 mm Hg after a combined procedure and 14.7 mm Hg after a stand-alone procedure. The median percent reduction in IOP from baseline was 24% at 1 year and 30% at 2 years.
In group 2, patients remained controlled with a modest but not statistically significant IOP decrease from baseline through 2 years. The median percent reduction in IOP was 3% at 1 year and 9% at 2 years.
Half of the patients were maintained on one or two medications, and the proportion of patients without medications increased from 12.5% at baseline to 34.7% at 1 year and 33.3% at 2 years; 16.7% of patients were on four or more medications at baseline, decreasing to 5.6% at 1 year and 3% at 2 years.
No device-related adverse events were reported during the extended follow-up.
“The present study demonstrates durable and stable control of IOP, medication usage significantly lower than pre-surgical baseline, with no emergent safety concerns for 2 years or more,” the authors wrote in the study abstract.
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Campbell A, et al. Canaloplasty and trabeculotomy in eyes with open-angle glaucoma (OAG): Two-year outcomes from the ROMEO study. Presented at: Women in Ophthalmology Summer Symposium; Aug. 24-27, 2023; Marco Island, Florida.
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