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

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.