ELIOS Excimer Laser Trabeculostomy with Phacoemulsification in Primary Open-Angle Glaucoma: 24-Month Outcomes of Pivotal Trial.

Abstract

Purpose: To evaluate 24-month safety and effectiveness of excimer laser trabeculostomy combined with phacoemulsification in patients with mild-to-moderate primary open-angle glaucoma (POAG).

Design: Prospective, multicenter, non-randomized pivotal investigational device exemption trial (NCT04899063).

Participants: Adults (≥45 years) with mild-to-moderate POAG, operable age-related cataract, medicated intraocular pressure (IOP) ≤24 mmHg on 1-3 ocular hypotensive medications, and unmedicated diurnal IOP (DIOP) 22-34 mmHg after washout.

Methods: Patients underwent phacoemulsification with intraocular lens implantation followed by excimer laser trabeculostomy (ELIOS System; Bausch + Lomb) and were followed for 24 months. Coprimary effectiveness endpoints were compared with prespecified performance goals derived from phacoemulsification-only control arms of other pivotal minimally invasive glaucoma surgery (MIGS) trials.

Main outcome measures: Coprimary endpoints were proportion of patients achieving ≥20% reduction in unmedicated mean DIOP from baseline at months 12 and 24 (performance goals >79% and >68.5%) and mean change in unmedicated DIOP at the same timepoints (performance goals ≤-7.2 and ≤-6.15 mmHg). Safety outcomes included adverse events, endothelial cell density (ECD), corrected distance visual acuity, visual field, and pachymetry.

Results: A total of 318 patients underwent the procedure (mean±SD age, 70.3±7.3 years; medicated IOP at screening, 17.05±3.01 mmHg; unmedicated DIOP at baseline, 24.53±2.51 mmHg). Both coprimary endpoints were met at months 12 and 24: a ≥20% reduction in unmedicated DIOP was achieved by 84.2% and 76.1% of patients (P=0.0116 and P=0.0018 vs. performance goals), respectively, and the mean±SE change in unmedicated DIOP was -8.17±0.21 mmHg and -7.35±0.22 mmHg (both P<0.0001 vs. performance goals), respectively. Mean DIOP decreased to 15.98 mmHg at month 12 and 16.76 mmHg at month 24. At month 23, 82.0% of patients were medication-free. No intraoperative adverse events occurred during the ELIOS procedure, and the postoperative safety profile in this population was consistent with that expected following phacoemulsification alone. ECD reduction occurred early and stabilized from month 3 through month 24.

Conclusions: Through 24 months, excimer laser trabeculostomy with phacoemulsification provided sustained, clinically meaningful reductions in unmedicated DIOP and medication use, with a favorable safety profile, supporting its use as a MIGS option in patients with mild-to-moderate POAG undergoing cataract surgery.