Br J OphthalmolAugust 202118 citations

Direct selective laser trabeculoplasty in open angle glaucoma study design: a multicentre, randomised, controlled, investigator-masked trial (GLAUrious).

Congdon Nathan, Azuara-Blanco Augusto, Solberg Yoram, Traverso Carlo E, Iester Michele, Cutolo Carlo Alberto, Bagnis Alessandro, Aung Tin, Fudemberg Scott J, Lindstrom Richard

View on PubMed DOI: 10.1136/bjophthalmol-2021-319379

AI Summary

This study compares a new direct selective laser trabeculoplasty (DSLT) to standard SLT for open-angle glaucoma. It aims to determine if DSLT is effective and non-inferior in lowering eye pressure, offering a potentially broader treatment option.

Abstract

Introduction

Laser trabeculoplasty is an effective and widely used treatment for glaucoma. A new laser technology, the Eagle direct selective laser trabeculoplasty (DSLT) device, may provide automated, fast, simple, safe and effective laser treatment for glaucoma in a broader range of clinical settings. This trial aims to test the hypothesis that translimbal DSLT is effective and not inferior to selective laser trabeculoplasty (SLT) in reducing intraocular pressure (IOP) in open angle glaucoma (OAG).

Methods and analysis: This is a multicentre, randomised, controlled, investigator-masked study. The primary efficacy outcome is intergroup difference in mean change from baseline IOP measured at 6 months. Secondary outcomes include mean percentage reduction in IOP at 3, 6 and 12 months; proportion of participants with at least 20% reduction in IOP from baseline at 6 months; change in ocular hypotensive medications at 12 months and evaluation of safety. Participants were aged >= 40 years with OAG, including exfoliative or pigmentary glaucoma, or ocular hypertension with untreated or washed out IOP 22-35 mm Hg.

Treatments: DSLT: 120 shots, 3 ns, 400 µm spot size, energy 1.4-1.8 mJ delivered at the limbus over 2 s. SLT: approximately 100 shots, 3 ns, 400 µm spot size administered 360 degrees at the limbus using any gonioscopy lens, energy 0.3-2.6 mJ. A sample size of 164 is sufficient to detect a non-inferiority margin of 1.95 mm Hg for change from baseline IOP.

Clinical trial registration number: NCT03750201, ISRCTN14033075.

MeSH Terms

HumansTrabeculectomyGlaucoma, Open-AngleIntraocular PressureLaser TherapyGlaucomaTreatment Outcome

Shields Classification

Ch. 2Intraocular Pressure and Tonometry

Ch. 11Chronic Open-Angle Glaucoma and Normal Tension Glaucoma

Ch. 37Principles of Laser Surgery for Glaucoma

Key Concepts6

The GLAUrious trial aims to test the hypothesis that translimbal direct selective laser trabeculoplasty (DSLT) is effective and not inferior to selective laser trabeculoplasty (SLT) in reducing intraocular pressure (IOP) in open angle glaucoma (OAG).

TreatmentRCTMulticentre, randomised, controlled, investigator-masked studyn=164 participantsCh28Ch37

The primary efficacy outcome for the GLAUrious trial is the intergroup difference in mean change from baseline intraocular pressure (IOP) measured at 6 months.

MethodologyRCTMulticentre, randomised, controlled, investigator-masked studyn=164 participantsCh28

Participants in the GLAUrious trial were aged >= 40 years with open angle glaucoma (OAG), including exfoliative or pigmentary glaucoma, or ocular hypertension with untreated or washed out intraocular pressure (IOP) 22-35 mm Hg.

MethodologyRCTMulticentre, randomised, controlled, investigator-masked studyn=164 participantsCh11Ch15

Direct selective laser trabeculoplasty (DSLT) treatment in the GLAUrious trial involved 120 shots, 3 ns pulse duration, 400 µm spot size, and energy 1.4-1.8 mJ delivered at the limbus over 2 seconds.

TreatmentRCTMulticentre, randomised, controlled, investigator-masked studyn=164 participantsCh37

Selective laser trabeculoplasty (SLT) treatment in the GLAUrious trial involved approximately 100 shots, 3 ns pulse duration, 400 µm spot size administered 360 degrees at the limbus using any gonioscopy lens, and energy 0.3-2.6 mJ.