Abstract
Purpose :
Effective first-line treatment of open-angle glaucoma (OAG) is limited by non-adherence to medication and lack of access to selective laser trabeculoplasty (SLT). A translimbal, efficacious, cost-effective, widely-accessible, treatment for OAG was developed. Direct Selective Laser Trabeculoplasty (DSLT) is a novel, automated, non-contact procedure to reduce intraocular pressure (IOP) in OAG patients, which does not requires a goniolens or the training required for traditional SLT. GLAUrious (NCT03750201) was an OAG treatment trial to assess the safety and efficacy of DSLT, compared with SLT.
Methods :
In this evaluator-masked, controlled study, patients aged ≥40 years with ocular hypertension or OAG, naïve or using up to 3 hypotensive medications, and an untreated/washout IOP 22–35 mmHg were recruited at 13 international eye centres and randomised 1:1 to receive DSLT or SLT and followed up for 12 months.
Results :
Randomized 84 patients were treated by DSLT and 77 by SLT. Baseline patient and eye characteristics were similar between treatment groups. DSLT procedure provided a mean (±SE) reduction of unmedicated IOP at 6 months of 5.46 ± 0.51 mmHg (95% CI -6.48 to -4.45), compared with 6.16 ± 0.53 mmHg (95% CI -7.21 to -5.11) for the SLT group. The difference between mean reduction in IOP between the two groups (SLT-DSLT) was -0.70 mmHg (95% CI -2.15 to 0.76; p=0.091). At 12 months, DSLT subjects had a mean reduction in non-washed out IOP from screening of -3.20 ±0.38 mmHg, similarly to the SLT subjects with a mean reduction of -3.28 ± 0.40 mmHg. The mean (±SD) number of medications used by the DSLT group was reduced by approximately 50% from 1.19 (1.01) at screening to 0.63 (0.94) at 12 months, similarly to the SLT group decrease from 1.22 (0.98) to 0.68 (0.94) at 12 months. Over half of patients were medication free at 12 months - 61.7% of DSLT and 59.5% of SLT subjects. No safety concerns were identified.
Conclusions :
This study demonstrated that DSLT is safe and effective in providing a meaningful IOP reduction that is sustained to 12 months. DSLT is poised to serve the growing clinical need in glaucoma care for greater availability of laser trabeculoplasty due to the emergence of SLT as a first-line treatment, given the major limitations of topical medical therapy and due to the increase in the patient population.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.