A Multicentre, Randomised, Controlled Non-Inferiority Study Of Direct Selective Laser Trabeculoplasty In Open Angle Glaucoma And Ocular Hypertension At 12 Months (Glaurious Trial)

Published 2023 - 41st Congress of the ESCRS

Reference: FP04.06 | Type: Free paper | DOI: 10.82333/h510-ps14

Authors: Nathan Congdon ¹ , Gus Gazzard ² , Thomas W Samuelson ³ , Augusto Azuara-Blanco ¹ , Carlo Enrico Traverso ⁴ , Peng T Khaw* ² , Eytan Z Blumenthal ⁵ , Keta Gomelauri ⁶ , Monika Zaliniyan ⁷ , Yoram Solberg ⁸ , Michael Belkin ⁹

¹Centre for Public Health, Queen’s University Belfast,Belfast, United Kingdom,United Kingdom, ²NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology and the NIHR Moorfields Clinical Research Facility,London,United Kingdom, ³Minnesota Eye Consultants, Minneapolis, MN, United States,Minneapolis, MN,United States;Department of Ophthalmology,University of Minnesota,Minneapolis, MN,United States, ⁴Clinica Oculistica Università di Genova,Genova,Italy, ⁵Department of Ophthalmology,Rambam Health Care Campus, Haifa, Israel,Haifa,Israel;Ruth and Bruce Rappaport Faculty of Medicine,Technion Israel Institute of Technology,Haifa,Israel, ⁶Javrishvili Eye Clinic Oftalmij, Tbilisi, Georgia,Tbilisi,Georgia, ⁷Akhali Mzera Eye Clinic,Tbilisi,Georgia, ⁸BELKIN Vision Ltd,Yavne, Israel,Israel, ⁹BELKIN Vision Ltd,Yavne, Israel,Israel;Sheba Medical Centre,Goldschleger Eye Research Institute, Tel Aviv University,Tel Hashomer,Israel

Purpose

First-line treatment of open-angle glaucoma (OAG) and ocular hypertension (OHT) is limited by non-adherence to daily topical hypotensive medication and by lack of access to selective laser trabeculoplasty (SLT). Evidence-based, cost-effective, and widely-accessible treatment options for OAG and OHT are needed, to maximise access to treatment and improve long-term patient outcomes. Direct-SLT (DSLT) is a novel, automated, non-contact laser procedure to reduce intraocular pressure (IOP) that can be administered without a goniolens or the training required for conventional SLT. GLAUrious (NCT03750201) was a clinical trial to assess the safety and efficacy of DSLT, compared with conventional SLT, in patients with OAG and OHT.

Setting

Thirteen sites across the UK, Italy, Israel and Georgia.

Methods

In this evaluator-masked, randomised, controlled, non-inferiority study, patients aged ≥40 years with OAG or OHT, naïve or up to 3 hypotensive medications, and untreated/washout IOP 22–35 mmHg were recruited between November 2018 and April 2021. Eligible patients were randomised 1:1 to receive DSLT using the Eagle device (BELKIN Vision) or SLT. Patients were followed-up at 12 months. The primary outcome was between-group difference in mean IOP change from baseline. Hypotensive medications use was also measured. The rate of adverse events in each treatment group was evaluated.

Results

The mPP group was composed of 84 DSLT and 77 SLT patients. The mean reduction in non-washed out IOP at 12 months was similar between groups (-3.20 ± 0.38 mmHg with SLT vs -3.20 ±0.40 mmHg with DSLT), a difference in mean reduction in IOP (SLT-DSLT) of 0.01 (95% CI -1.09 to 1.10; p<0.001). The mean (±SD) number of medications used by the DSLT group was reduced by 50%, from 1.19 (1.01) at screening to 0.63 (0.94) at 12 months, similar to the SLT group (1.22 (0.98) at screening to 0.68 (0.94)). At 12 months, 61.7% of the DSLT group were drop-free vs. 59.5% of the SLT group. The majority of drop-free patients at screening remained medication-free at 12 months (70% [19/27] with DSLT vs 73% [19/27] with SLT). No safety concerns were identified.

Conclusions

This study demonstrated that DSLT with the Eagle device is safe and effective in providing a clinically meaningful reduction in IOP that is sustained out to 12 months. DSLT is poised to serve an immense and growing clinical need in glaucoma care for greater availability of SLT due to the emergence of laser trabeculoplasty as a first-line treatment, given the major limitations of topical medical therapy and due to the growing population of patients suffering from OAG and OHT.