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

Abstract

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 6-month primary end point did not achieve statistical noninferiority compared with conventional SLT. Nonetheless, DSLT was well tolerated and provided an effective reduction in IOP that was sustained for 12 months. Failure to demonstrate noninferiority does not prove inferiority; DSLT remains an effective option in the early treatment paradigm and can be considered as a first-line treatment when SLT is not readily accessible.

Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Keywords: Direct selective laser trabeculoplasty; Intraocular pressure; Ocular hypertension; Open-angle glaucoma; Selective laser trabeculoplasty.