Well-designed studies needed to support reimbursement for canaloplasty
Click Here to Manage Email Alerts
WAILEA, Hawaii — Canaloplasty has shown through the years to be a safe and effective procedure for primary open-angle glaucoma, but more evidence from well-designed studies is needed to support reimbursement, according to one specialist.
Following the recent local coverage determination (LCD) changes proposed for Medicare reimbursement, current and future MIGS procedures, including canaloplasty, must be FDA approved and demonstrate effectiveness of 20% or greater IOP reduction over 24 months by moderate-high quality literature.
“[A lot] of the studies [on canaloplasty] are retrospective and single arm,” Jacob W. Brubaker, MD, said at Hawaiian Eye 2024.
ROMEO was a 2-year retrospective multicenter study on the Omni surgical system (Sight Sciences), with no washout, including 72 patients treated stand-alone or in combination with cataract surgery. It met the endpoint of pressure reduction or pressure 6 mm Hg to 18 mm Hg in about 75% of patients. One-third of patients were medication free.
The GEMINI study was a 1-year multicenter study of Omni combined with phaco in 149 patients, of which 120 were available for analysis. It was prospective, with washout but no control arm. IOP reduction greater than 20% was achieved in 84% of patients, and 80% were medication free.
The ABiC study was a single-center 3-year study on iTrack (Nova Eye Medical) stand-alone vs. combined with phaco. Results were good, with 95% of patients down to 17 mm Hg or less, but the design was retrospective, with no washout and no control arm.
The last study Brubaker reviewed was a multicenter 6-month study with the Streamline surgical system (New World Medical) combined with phaco. It was prospective, with washout but with a low number of patients and no controls. IOP reduction was 20% or greater in 89.5% of patients.
“We have emerging evidence, and this is maybe a little bit of a wakeup call for all of us to try and get better data, trying to fit in line with what they want so that we have more evidence on our side,” Brubaker said.
Collapse
Brubaker JW. The evidence supporting canaloplasty reimbursement. Presented at: Hawaiian Eye 2024; Jan. 13-19, 2024; Wailea, Hawaii.
Click Here to Manage Email Alerts