Summary
PURPOSE: Excimer laser trabeculostomy is a minimally invasive glaucoma surgery (MIGS) that enables precision removal of trabecular meshwork (TM) to facilitate aqueous outflow without collateral damage. The ELIOS device (Bausch+Lomb) creates microchannels in the TM, with clinical trial data showing sustained reduction in intraocular pressure (IOP) and IOP-lowering medications (meds); both are important treatment goals in glaucoma. The purpose of this study was to evaluate the long-term effectiveness of ELIOS combined with phacoemulsification (phaco) in patients with elevated IOP over a five-year follow-up in a real-world setting.
SETTING: This was a retrospective, single-centre study of patients with mild-to-moderate open-angle glaucoma (OAG) or ocular hypertension (OHT) with visually significant cataracts requiring surgery. Combined Phaco-Elios procedures were performed between October 2017 and December 2021.
METHODS: The ELIOS procedure uses a 308-nm XeCL excimer laser to create ten 210-µm diameter microchannels in the TM within a 90–110° treatment area to optimise aqueous outflow. Outcomes included mean IOP, mean meds, distribution of meds, and best-corrected visual acuity (BCVA) through 5 years of follow-up. Success was defined by three criteria: A. IOP reduction ≥20% without further surgery; B. IOP ≤18 mmHg without meds; C. IOP ≤ preoperative IOP without meds. Safety was also assessed. A total of 129 eyes of 96 patients were included in the analysis, with a mean±standard deviation (SD) age of 73.02±23 years, and 72% were female.
RESULTS: At baseline, mean±SD meds was 1.74±0.75, BCVA was 0.4±0.15 (decimal), non-medicated IOP was 25.44±4.15 mmHg (n=129 eyes), and medicated IOP was 20.8±0.32 mmHg. At 5 years of follow-up, mean±SD medicated IOP was 17.5±0.37 mmHg, corresponding to a 16% reduction (p<0.001). Mean±SD meds was 0.50±0.68, corresponding to a 71% reduction (p<0.001), with 62% of patients requiring 0 meds and 0% requiring ≥3 meds. Mean BCVA was 0.8 decimal (p<0.001). The cumulative success rate was 47.1%, 57.5%, and 65.0%, at 1 year, and 41.4%, 38.0% and 41.4% at 5 years, for the A, B, and C criteria, respectively. Nine cases (7%) required additional surgery by 5 years of follow-up. No major adverse events were recorded. Three patients were lost to follow-up by study end.
CONCLUSIONS: In this study of patients with OAG and OHT undergoing phaco-ELT, the mean IOP was reduced to below the European Glaucoma Society suggested target range for early glaucoma (<20 mmHg and ≥20% reduction) and approaching that for mild-to-moderate glaucoma (<17 mmHg and ≥30% reduction), demonstrating a clinically meaningful outcome. The sustained reduction in meds decreases reliance on medication adherence to sustain outcomes and is associated with improved patient quality of life, which is an important treatment goal. These outcomes are reflected in the three predefined success criteria being met and maintained through 5 years. BCVA was also improved at 5 years.