PURPOSE: ELIOS (Bausch + Lomb) is an ophthalmic excimer laser trabecular bypass minimally invasive glaucoma surgery (MIGS) system. This trial assessed the effectiveness and safety of the MIGS system to reduce intraocular pressure (IOP) in adults with primary open-angle glaucoma (POAG) undergoing cataract surgery. Study safety will be focus of this paper.

METHODS: This prospective, non-randomized clinical trial (NCT04899063) enrolled patients aged ≥45 years with mild-to-moderate POAG at 20 sites in the USA. Additional eligibility criteria included operable age-related cataract eligible for phacoemulsification with best-corrected visual acuity (BCVA) ≤ 20/40, medicated IOP of ≤24 mmHg, and unmedicated diurnal IOP of 22–34 mmHg. Patients meeting all eligibility criteria underwent the ELIOS procedure after uncomplicated cataract surgery, with 24-months follow up. Key safety outcomes were the incidence of adverse events (AEs) and endothelial cell density (ECD) loss from baseline, and distribution of postoperative BCVA. Results reflect findings at 12-month.

RESULTS: 318 patients underwent the procedure (mean±SD age 70.2±7.4 years). At 12-mo, 144 ocular AEs were reported in 107 patients (33.6%); 68% occurred within 1-mo, and 32% between Months 1–12. 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%. Most ocular AEs were mild or moderate and occurred in the early postop without clinically meaningful sequelae. ECD loss demonstrated early postoperative reduction with stabilization by Month 3. All patients achieved BCVA of 20/40 or better at 12-mo (n=307). No unanticipated device effects or procedure-related intraoperative AEs occurred.

CONCLUSIONS: Excimer laser trabeculostomy MIGS with ELIOS was associated with a low rate of serious AEs, and over 66% of patients not experiencing any AEs at 12 months. Reported AEs are in-line with those described in the literature for standalone cataract surgery. No intraoperative complications or unanticipated adverse device effects were reported.