Background

Glaucoma 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.

Methods

We 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.

Findings

840 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).

Interpretation

SLT 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.

Funding

Christian Blind Mission, Seeing is Believing Innovation Fund, and the Wellcome Trust.

Translations

For the Kiswahili, French and Portuguese translations of the abstract see Supplementary Materials section.

中文翻译：

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坦桑尼亚选择性激光小梁成形术与 0·5% 噻吗洛尔滴眼液治疗青光眼的比较：一项随机对照试验

 背景

青光眼是全世界视力丧失的主要原因，据报道，非洲地区患病率和发病率最高。用于控制青光眼的最常见的低成本治疗方法是长期使用噻吗洛尔滴眼液。然而，依从性低是一个重大挑战。我们的目的是研究选择性激光小梁成形术（SLT）在控制开角型青光眼患者的眼内压（IOP）方面是否优于噻吗洛尔滴眼液。

 方法

我们在坦桑尼亚莫希乞力马扎罗基督教医疗中心眼科进行了一项双臂、平行组、单盲随机对照试验。符合资格的参与者（年龄≥18岁）患有开角型青光眼且眼压高于21毫米汞柱，并且没有哮喘或青光眼手术或激光病史。参与者被随机分配 (1:1) 接受 0·5% 噻吗洛尔滴眼液，每日两次或接受 SLT。主要结局是随机分组后 12 个月时两组治疗成功的眼睛比例，定义为根据青光眼严重程度，眼压低于或等于目标压力。允许重新解释滴眼剂的使用或重复 SLT 一次。主要分析是通过修改意向治疗，使用逻辑回归排除失访的参与者；使用广义估计方程来调整眼睛之间的相关性。该试验已在泛非临床试验注册中心注册，注册号为 PACTR201508001235339。

 发现

840 名患者接受了资格筛查，其中 201 名（24%）参与者（382 只符合条件的眼睛）在 2015 年 8 月 31 日至 2017 年 5 月 12 日期间入组。100 名（50%）参与者（191 只眼睛）被随机分配至噻吗洛尔组SLT 组有 101 只（50%；191 只眼睛）。一年后，对 382 只眼睛中的 339 只 (89%) 进行了分析。噻吗洛尔组 176 只眼中有 55 只眼 (31%) 治疗成功（55 只眼中有 16 只眼 [29%] 需要重复给药咨询），SLT 组 163 只眼中有 99 只眼 (61%) 治疗成功（33 只眼 [33%]） 99 只眼睛需要重复 SLT；比值比 3·37 [95% CI 1·96–5·80]；p<0·0001）。噻吗洛尔组的 10 名参与者 (10%) 和 SLT 组的 8 名参与者 (8%) 发生了不良事件（大多与眼部事件无关）(p=0·61)。

 解释

在坦桑尼亚，SLT 治疗开角型高压青光眼患者一年的效果优于噻吗洛尔滴眼液。 SLT 有潜力改变撒哈拉以南非洲地区青光眼的治疗，即使是在晚期青光眼患病率很高的地区。

 资金

Christian Blind Mission、Seeing is Believe Innovation Fund 和 Wellcome Trust。

 翻译

有关摘要的斯瓦希里语、法语和葡萄牙语翻译，请参阅补充材料部分。