Long-Term Safety and Effectiveness of STREAMLINE Canaloplasty with Phacoemulsification in a Hispanic Population with Open-Angle Glaucoma

Abstract

Purpose To report long-term clinical outcomes from a multicenter study evaluating STREAMLINE® Surgical System (STREAMLINE) canaloplasty, a minimally invasive glaucoma surgery (MIGS), combined with phacoemulsification in eyes with mild to moderate open-angle glaucoma (OAG). Design Retrospective extension of a prospective, multicenter, interventional study. Participants Participants were those in the original study who provided consent for retrospective long-term data collection. Methods All eyes in this single-arm, retrospective extension study underwent STREAMLINE canaloplasty performed in combination with phacoemulsification between November 2021 and April 2022 at two sites in Latin America. Main Outcome Measures The primary effectiveness outcome was the reduction in mean intraocular pressure (IOP) from Screening to last follow-up. Secondary effectiveness outcomes included mean change in topical IOP-lowering medication count from Screening compared to last follow-up. Safety assessments included visual acuity, visual field mean deviation, and incidence of adverse events (AEs). Results Participants (n=28) at 2 of the 3 sites in the original study (n=43, 65.1%) consented to have retrospective data collected as part of this extension study. Average length of follow-up was 24.2±4.4 months (M24). Mean IOP (17.1±3.0 mmHg) and IOP-lowering medication count (1.86±0.80) at Screening decreased to 15.13±3.25 mmHg (p=0.002) and 0.54±1.17 (p<0.001), respectively. At M24, 92.9% of eyes were on the same or fewer medications compared to screening and 78.6% were medication free. No AEs were reported in the extension study (M12 to last follow-up). Conclusions Canaloplasty with the STREAMLINE® Surgical System in combination with phacoemulsification provides clinically and statistically significant reduction in both IOP and the need for IOP-lowering medications in eyes with mild-moderate OAG in a Hispanic adult population through an average of 24 months post-operatively.