12-month visual and safety outcomes of the ELIOS procedure with cataract surgery in primary open-angle glaucoma

Purpose: To characterize early safety and visual outcomes through 12 months following combined phacoemulsification and ELIOS excimer laser trabeculostomy procedure in patients with mild-to-moderate primary open-angle glaucoma (POAG). Setting: Conducted at 20 US sites. Design: Prospective, multicenter, non-randomized clinical trial (NCT04899063). Methods: Adults aged ≥45 years with cataract and mild-to-moderate POAG underwent phacoemulsification with intraocular lens implantation followed immediately by the ELIOS procedure. Corrected distance visual acuity (CDVA), pachymetry, endothelial cell density (ECD), visual field measurements, and adverse events (AEs) were reported up to 12 months. Results: A total of 318 patients underwent the procedure; mean±SD age was 70.3±7.3 years, 172 (54.1%) were female, and 263 (82.7%) were White. Five intraoperative AEs were reported during cataract procedure and none during ELIOS procedure. Visual recovery was rapid and sustained: at month 12, all patients achieved CDVA 20/40 or better; CDVA was <1 line of baseline in 28.0% of patients and improved by ≥1 line in 214 (69.8%), and no losses ≥2 lines. Corneal edema occurred predominantly early and resolved without sequelae. ECD loss occurred early then stabilized; median change and median percent change in ECD at month 12 were −237.0 cells/mm 2 and −9.10%, respectively. Through 12 months, 73 postoperative ocular AEs were reported in 17.3% of patients; the most common AEs were anterior chamber cell/flare requiring increased or reinitiated steroid therapy (5.7%), and worsening of visual field mean deviation by ≥2.5 dB from baseline (4.4%). Conclusions: Combined phacoemulsification-ELIOS was associated with a safety profile consistent with published outcomes following phacoemulsification alone, with predominantly early, self-limited postoperative events.