Abstract

SummaryBackgroundGlaucoma is a major cause of sight loss worldwide, with the highest regional prevalence and incidence reported in Africa. The most common low-cost treatment used to control glaucoma is long-term timolol eye drops. However, low adherence is a major challenge. We aimed to investigate whether selective laser trabeculoplasty (SLT) was superior to timolol eye drops for controlling intraocular pressure (IOP) in patients with open-angle glaucoma.MethodsWe did a two-arm, parallel-group, single-masked randomised controlled trial at the Eye Department of Kilimanjaro Christian Medical Centre, Moshi, Tanzania. Eligible participants (aged ≥18 years) had open-angle glaucoma and an IOP above 21 mm Hg, and did not have asthma or a history of glaucoma surgery or laser. Participants were randomly assigned (1:1) to receive 0·5% timolol eye drops to administer twice daily or to receive SLT. The primary outcome was the proportion of eyes from both groups with treatment success, defined as an IOP below or equal to target pressure according to glaucoma severity, at 12 months following randomisation. Re-explanation of eye drop application or a repeat SLT was permitted once. The primary analysis was by modified intention-to-treat, excluding participants lost to follow-up, using logistic regression; generalised estimating equations were used to adjust for the correlation between eyes. This trial was registered with the Pan African Clinical Trials Registry, number PACTR201508001235339.Findings840 patients were screened for eligibility, of whom 201 (24%) participants (382 eligible eyes) were enrolled between Aug 31, 2015, and May 12, 2017. 100 (50%) participants (191 eyes) were randomly assigned to the timolol group and 101 (50%; 191 eyes) to the SLT group. After 1 year, 339 (89%) of 382 eyes were analysed. Treatment was successful in 55 (31%) of 176 eyes in the timolol group (16 [29%] of 55 eyes required repeat administration counselling) and in 99 (61%) of 163 eyes in the SLT group (33 [33%] of 99 eyes required repeat SLT; odds ratio 3·37 [95% CI 1·96–5·80]; p<0·0001). Adverse events (mostly unrelated to ocular events) occurred in ten (10%) participants in the timolol group and in eight (8%) participants in the SLT group (p=0·61).InterpretationSLT was superior to timolol eye drops for managing patients with open-angle high-pressure glaucoma for 1 year in Tanzania. SLT has the potential to transform the management of glaucoma in sub-Saharan Africa, even where the prevalence of advanced glaucoma is high.FundingChristian Blind Mission, Seeing is Believing Innovation Fund, and the Wellcome Trust.TranslationsFor the Kiswahili, French and Portuguese translations of the abstract see Supplementary Materials section.

Highlights

  • Glaucoma is a group of diseases that affect the optic nerve and lead to a progressive and irreversible loss of vision

  • The primary outcome was the proportion of eyes from both groups with treatment success, defined as an intraocular pressure (IOP) below or equal to target pressure according to glaucoma severity, at 12 months following randomisation

  • The primary analysis was by modified intention-to-treat, excluding participants lost to follow-up, using logistic regression; generalised estimating equations were used to adjust for the correlation between eyes

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Summary

Introduction

Glaucoma is a group of diseases that affect the optic nerve and lead to a progressive and irreversible loss of vision. Glaucomas are the most frequent cause of irreversible blindness.[4] Africa has the highest prevalence of glaucoma of all world regions, which is estimated to be 4·8%, as well as the highest incidence, with an expected increase from 10·31 million new cases in 2020 to 19·14 million in 2040 due to increasing life expectancy and population growth.[5] The prevalence of blindness due to glaucoma is higher in sub-Saharan Africa than in any other world region.[4] This situation is met by limited resources in many regions of sub-Saharan Africa; the mean number of ophthalmologists is 3·7 per million people in low-income countries versus 76·2 per million people in high-income countries.[6]

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