Circumferential canaloplasty, trabeculotomy provide IOP control for 2 years
Reviewed by Blake Williamson, MD
The 2-year results of the ROMEO study,1 which evaluated the Omni Surgical System (Sight Sciences), showed that the significant reductions in IOP and medication use at 12 months continued to 24 months in patients with open-angle glaucoma. This is the longest multicenter study of the Omni Surgical System technology to date in both stand-alone and combination cataract surgery procedures.
“This longer-term data set representing patients treated at multiple centers throughout the country both at the time of cataract surgery and as a stand-alone treatment should give eye surgeons even greater confidence about the safety and durability of efficacy of the Omni Surgical System technology,” Blake Williamson, MD, a principal investigator in the ROMEO study, said. “Knowing that the OMNI system maintains effectiveness through 2 years and beyond is very reassuring to me and my patients.”
The ROMEO study was continued because the 12 months of the initial study represent a short period when considering that glaucoma is a chronic, lifelong disease. As the study investigators pointed out, “Longer follow-up is desirable and indeed essential to assess the durability of IOP-lowering effectiveness and for the detection of potential delayed safety signals.”
This retrospective investigational review B\board–approved study was conducted at 7 ophthalmology practices in the United States and sought to determine the safety and effectiveness over 24 months in eyes of patients who had been treated with circumferential canaloplasty and trabeculotomy and followed for 12 months. All eyes in the study had mild to moderate glaucoma and had undergone circumferential canaloplasty and trabeculotomy either with cataract surgery or as a stand-alone procedure.
The main outcome measures were the mean IOP, mean number of ocular hypotensive medications, mean change in the number of medications, proportion of patients with a reduction in IOP of 20% or more or with an IOP of 18 mm Hg or less, and proportion of patients who no longer needed antiglaucoma medication. The safety outcomes included adverse events and the need for secondary surgical interventions, Williamson said.
A total of 72 patients with pseudophakia were included in this follow-up study; all had been part of the 12-month ROMEO study. The patients were divided into 2 groups based on the preoperative IOP: more than 18 mm Hg (group 1) and 18 mm Hg or less (group 2).
Williamson reported that the mean follow-up time was 2.1 years (range, 1.4-3.5). In group 1 patients who underwent cataract surgery, the mean 2-year IOP was 15.6 mm Hg, a 28% decrease from baseline, with patients on 1.4 medications, a 39% decrease. In group 1 patients who underwent a stand-alone procedure, the mean IOP was 14.7 mm Hg, a 33% decrease from baseline, with patients on 1.6 medications, a 15% decrease.
In group 2 patients who underwent cataract surgery, the mean IOP was 13.7 mm Hg, a decrease of 4.2%, with patients on 1.2 medications, a decrease of 35%. In group 2 patients who underwent a stand-alone procedure, the mean IOP was 13.3 mm Hg, a reduction of 14.7%, with patients on 1.2 medications, a reduction of 46%.
Williamson also reported that at the 2-year time point, 75% of the 72 patients had either a decrease in IOP of 20% or more or an IOP between 6 and 18 mm Hg, with no increase in medications or the need for a secondary surgical procedure. At 2 years, one-third of the 72 patients were medication free, whereas 9 of 72 had been presurgically.
During the second 12-month period of the ROMEO study, no adverse events were related to the device. Six eyes (8.3%) required additional surgical or laser intervention for IOP control after 12 months. Results from the study concluded that circumferential canaloplasty and trabeculotomy provide effective IOP control that is sustained for 2 years or more.
The investigators explained that the safety and effectiveness data beyond 12 months supporting laser or surgical intervention in glaucoma are essential for surgeons to strategically plan individualized care for their patients with glaucoma. “One size does not fit all, [because] stage of disease, degree of disability, age and life expectancy, ability to self-administer medications reliably, and cost of therapy must all be considered,” they said. “The span of time that a given treatment can be reasonably expected to provide the necessary level of IOP control is a key element in this planning.”
Moreover, investigators noted that results from the present study extend the follow-up for IOP, medication, and safety outcomes of the original 12-month ROMEO study to 24 months and demonstrate continued and stable control of IOP, with medication usage similar to that at 12 months and significantly lower than the presurgical baseline, with a high level of safety. “Ab interno canaloplasty and trabeculotomy with the OMNI Surgical System is, therefore, a reasonable treatment option in mild to moderate glaucoma used in conjunction with cataract surgery or as a stand-alone procedure with demonstrable safety and efficacy through at least 2 years,” they concluded.