PURPOSE: This study aimed to evaluate the effectiveness and safety of the excimer laser trabecular bypass minimally invasive glaucoma surgery (MIGS) system in reducing the intraocular pressure (IOP) of adults with mild-to-moderate primary open-angle glaucoma (POAG) when used in combination with cataract surgery. The present analysis reports the effectiveness outcomes of the trial at 12-mo.

SETTING: This was a prospective, non-randomised, clinical trial at 20 sites in the USA (NCT04899063), with treatment between June 2021 and July 2023

METHODS: The ELIOS system (Bausch + Lomb) is a clinically-validated excimer laser trabecular bypass MIGS procedure. Key eligibility criteria included age ≥45 years, mild-to-moderate POAG, an operable age-related cataract eligible for PE with best-corrected visual acuity of 20/40 or worse, medicated IOP of ≤24 mmHg and unmedicated diurnal IOP (DIOP) of 22–34 mmHg. Eligible patients underwent the MIGS procedure after uncomplicated cataract surgery. The co-primary effectiveness endpoints were the proportion of patients achieving a decrease in medication-free mean DIOP of ≥20%, and mean change in medication-free DIOP, from baseline to 12 months.

RESULTS: A total of 318 pts with mean±standard deviation (SD) age of 70.2±7.4years (54% female) underwent the ELIOS combined procedure. At screening, mean±SD medicated IOP was 17.05±3.01mmHg; at baseline, unmedicated DIOP was 24.53±2.51mmHg. 84.2% of patients achieved a ≥20% decrease in unmedicated mean DIOP from baseline at 12mo, meeting the co-primary effectiveness endpoints (97.5% CI 79.59, 88.84; p=0.0116 vs performance goal of >79%). Mean DIOP change was −8.17mmHg (97.5% CI −8.65, −7.69; p<0.0001 vs performance goal of ≤−7.2 mmHg). From screening to Month 11, the mean±SD number of medications decreased from 1.5±0.7 at screening (N=318) to 0.2±0.7 at Month 11 (n=298), accompanied with sustained decrease in IOP throughout the follow-up.

CONCLUSIONS: In this clinical trial of pts with POAG undergoing cataract surgery in combination with the ELIOS procedure, both co-primary effectiveness endpoints were met. ELIOS demonstrated clinically meaningful and sustained reduction in unmedicated DIOP. The 34.5% reduction in mean DIOP at Month 12 aligns with recommended target reduction for mild-to-moderate glaucoma (≥25% reduction to below 17 mmHg). These results suggest the ELIOS procedure is an effective minimally invasive treatment option for reducing IOP in POAG patients undergoing cataract surgery.