Randomized Noninferiority Trial of Direct Selective Laser Trabeculoplasty in Open-Angle Glaucoma and Ocular Hypertension: GLAUrious Study

PURPOSE: Effective glaucoma treatment is limited by nonadherence to medications and access to selective laser trabeculoplasty (SLT). The GLAUrious study compared automated, gonioscopy-free, noncontact, image-guided direct selective laser trabeculoplasty (DSLT) with conventional SLT in open-angle glaucoma (OAG) and ocular hypertension (OHT) to reduce intraocular pressure (IOP). DESIGN: Prospective, multicenter, randomized, controlled, evaluator-masked noninferiority trial. Participants Participants aged ≥ 40 years with OAG or OHT, on 0–3 hypotensive medications at screening, and washout IOP of 22–35 mmHg at 14 centers. METHODS: After washout, 192 participants randomized 1:1 to DSLT (n = 99) or SLT (n = 93). Intraocular pressure was assessed before treatment and through 12 months after the procedure, with washout IOP at baseline and 6 months. Main Outcome Measures Difference between DSLT and SLT in mean IOP change from baseline to 6 months (noninferiority margin, –1.95 mmHg). Exploratory efficacy and safety outcomes were assessed over 12 months. RESULTS: Of 156 participants (81.3%) without major protocol deviations analyzed at 6 months, the mean ± standard error (SE) washout IOP reduction from baseline was 5.5 ± 0.5 mmHg (–20.6%) after DSLT and 6.2 ± 0.5 mmHg (–23.6%) after SLT. The between-group difference (SLT–DSLT) in mean IOP reduction was –0.7 mmHg (95% confidence interval [CI], –2.2 to 0.8 mmHg; P = 0.09 [not significant] for noninferiority). Of 161 participants (83.9%) without major protocol deviations analyzed at 12 months, mean ± SE nonwashout IOP reduction from screening was 3.2 ± 0.4 mmHg (–12.2%) after DSLT and 3.2 ± 0.4 mmHg (–9.4%) after SLT. The between-group difference in mean IOP reduction was 0.01 mmHg (95% CI, –1.1 to 1.1 mmHg; P < 0.001 for noninferiority). Safety profiles were similar between groups, although clinically nonsignificant punctate subconjunctival hemorrhage was more frequent in the DSLT group. Ocular AEs generally were mild and resolved without intervention. CONCLUSIONS: The ...