Abstract
Purpose :
Effective first-line treatment of open-angle glaucoma (OAG) is currently limited by non-adherence to daily topical hypotensive medication and by lack of access to selective laser trabeculoplasty (SLT). A worldwide need therefore exists for evidence-based, cost-effective, and widely accessible treatment options for OAG, with convenient modes of administration to maximise adherence to treatment and improve long-term outcomes. Direct selective laser trabeculoplasty (DSLT) is a novel, automated, non-contact procedure in which SLT-like laser beams are delivered to the limbus to reduce intraocular pressure (IOP) in patients with OAG, that can be administered within seconds, without the use of a gonioscope and the need for 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.
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 13 ophthalmology centres in the United Kingdom, Italy, Israel, and the Republic of Georgia. 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; 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 :
The 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.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.