Title: Glaurious, A Multicentre, Randomised, Controlled Non-Inferiority Study Of Direct Selective Laser Trabeculoplasty In Open Angle Glaucoma

Published 2022 - 40th Congress of the ESCRS

Reference: FPM04.11 | Type: Free paper | DOI: 10.82333/3qf2-hz15

Authors: Nathan Congdon* ¹ , Aung Tin ² , Michael Belkin ³ , Gus Gazzard ⁴ , Yoram Solberg ⁵ , Peng Tee Khaw ⁶ , Tom Samuelson ⁷ , Richard Lindstrom ⁸ , Dennis Lam ⁹ , Andrew Iwach ¹⁰ , Kuldev Singh ¹¹ , Xing-Huai Sun ¹² , Sarah Van Tassell ¹³ , Eytan Blumenthal ¹⁴ , Keta Gaumlauri ¹⁵ , Esther Hoffman ¹⁶ , Monika Zalinyan ¹⁷

¹Centre for Public Health,Queen's University Belfast,Belfast,United Kingdom;Orbis International,Orbis International,New York,United States, ²Singapore Eye Research Institute,Singapore National Eye Centre,Singapore,Singapore, ³Goldschleger Eye Research Institute,Tel Aviv University,Tel Aviv,Israel, ⁴Moorfields,London,United Kingdom, ⁵BELKIN Vision,Yavne,Israel, ⁶Moorfields Eye Hospital,London,United Kingdom, ⁷Minnesota Eye Consultants,Minneapolis,United States, ⁸Minnesota Eye Center,Minneapolis,United States, ⁹C-MER,Hong Kong,China, ¹⁰Glaucoma Center of San Francisco,San Francisco,United States, ¹¹Standford University of Medicine,San Francisco,United States, ¹²Fudan University,Shanghai,China, ¹³Weill Cornell Medical College,New York,United States, ¹⁴Rambam Health Care Campus,Haifa,Israel, ¹⁵10Javrishvili Eye Clinic Oftalmij,Tbilisi,Georgia, ¹⁶University Medical Center of the Johannes Gutenberg University Mainz,Mainz,Germany, ¹⁷Akhali Mzera Eye Clinic,Tbilisi,Georgia

Purpose

A need exists for evidence-based, cost-effective, and widely-accessible treatment options for OAG, with convenient modes of administration to maximise access to treatment and improve long-term patient outcomes. Direct selective laser trabeculoplasty (DSLT) is a novel, automated, non-contact laser procedure to reduce intraocular pressure (IOP) in patients with OAG, that can be administered within seconds, without the need for a goniolens or the specialised training required for traditional SLT. GLAUrious (NCT03750201) is a confirmatory clinical trial to assess the safety and efficacy of DSLT, compared with conventional SLT, in patients with OAG.

Setting

Thirteen ophthalmology centres in the United Kingdom, Italy, Israel, and the Republic of Georgia.

Methods

In this evaluator-masked, randomised, controlled, non-inferiority study, patients aged ≥40 years with ocular hypertension or OAG, including exfoliative or pigmentary glaucoma, and untreated/washout IOP 22–35 mmHg were recruited between November 2018 and April 2021 at Eligible patients were randomised 1:1 to receive DSLT or SLT. The primary outcome was between-group difference in mean IOP change from baseline to 6 months. Secondary 6-month outcomes were: proportion of patients with ≥20% reduction in unmedicated IOP from baseline; and change in mean number of topical hypotensive medications from screening. Rates of adverse events in each treatment group were also evaluated

Results

A total of 192 patients were randomised to receive treatment, 98 with DSLT and 94 with SLT. Baseline patient and eye characteristics were similar between treatment groups. Primary and secondary endpoints for non-inferiority of DSLT, compared with SLT, at 6-month follow-up will be presented.

Conclusions

Results of the GLAUrious study are expected to support use of DSLT as a widespread, convenient modality that can provide fast, effective laser treatment for OAG across a broad range of clinical settings. Given the prevalence of glaucoma, adoption of DSLT in global clinical practice has the potential to transform access to effective treatment, preserving sight for millions of people worldwide.