PURPOSE: This study aimed to evaluate the safety and effectiveness 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 on the safety outcomes of the trial.

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

METHODS: The ELIOS system 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. Safety assessments included ocular adverse events (AEs), endothelial cell density (ECD) loss from baseline, and postoperative BCVA through the follow-up period. These results correspond to the evaluations conducted at the 12-month follow-up.

RESULTS: A total of 318 pts underwent the procedure. Mean±SD age was 70.2±7.4 years (54% female). 5 AEs were reported during cataract extraction/IOL implantation, and no intraoperative complications or AEs were reported during the ELIOS procedure. 144 ocular AEs were documented in 107 pts (33.6%) through 12-mo follow up. Most events occurred within the first postoperative month (68%) and were mild to moderate without clinically significant sequelae. While early postoperative IOP elevations ≥10 mmHg were predominantly transient, the incidence of sustained or later-onset IOP elevation (≥1 month) was low at 1.5%. ECD loss demonstrated early postoperative reduction with stabilization by Month 3. BCVA ≥20/40 was achieved in all patients at 12-mo

CONCLUSIONS: The ELIOS excimer laser trabeculostomy procedure demonstrated a favourable long-term safety profile when combined with cataract surgery in patients with POAG. The low rate of serious ocular adverse events, absence of intraoperative complications, and stable endothelial cell outcomes support its use as a minimally invasive option for enhancing aqueous outflow during cataract surgery. These findings align with reported safety outcomes for standalone phacoemulsification and reinforce the clinical relevance of this combined approach.