Reddingius Peter F, Kelly Stephen R, Ometto Giovanni, Garway-Heath David F, Crabb David P
From the Department of Optometry and Visual Sciences (P.F.R., S.R.K., G.O., D.P.C.), School of Health and Psychological Sciences, City, University of London, London, United Kingdom.
NIHR Biomedical Research Centre (D.F.G.-H.), Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, United Kingdom.
Am J Ophthalmol. 2025 Jan;269:346-354. doi: 10.1016/j.ajo.2024.08.023. Epub 2024 Aug 28.
Evidence to support the hypothesis that visual field (VF) status can improve after initiation of intraocular pressure (IOP) reducing treatment is controversial. We take advantage of participant eligibility data from the United Kingdom Glaucoma Treatment Study (UKGTS) to test this hypothesis in newly diagnosed glaucomatous patients randomized to IOP-lowering therapy or placebo.
Multicentre, randomized, triple-masked, placebo-controlled trial.
Participants were newly diagnosed open-angle glaucoma patients in the UKGTS with eligibility and baseline data (n = 202 and n = 205 participants from the treatment and placebo groups, respectively). UKGTS eligibility data, including two reliable VFs (Humphrey 24-2 SITA Standard) and IOP measurements were compared to UKGTS trial baseline data acquired after allocation to treatment (topical prostaglandin analog) or placebo eye drops. Mean change in VF mean deviation (MD) and proportion of eyes that improved MD by more than different thresholds were compared across this interval in the treatment and placebo groups. Secondary analyses included stratifying the groups by level of IOP, level of VF loss, and age, along with pointwise analyses including change in subsets of VF locations. The main outcome measure was the mean change in VF MD.
Mean (standard deviation [SD]) time between eligibility/baseline visits and reduction in IOP was 12 (3) weeks and 4.8 (4.2) and 1.0 (3.6) mmHg for the treated and placebo eyes, respectively. Mean (SD) change in MD was almost the same for the treated (-0.03 [1.45] dB) and placebo groups (+0.08 [1.72] dB; P = .47). The proportions of participants with an MD improvement of 1 dB or more were similar for both groups (P = .25). No association was found between MD improvement and magnitude of IOP lowering. Stratifying data by IOP, level of VF loss and age did not reveal any differences between the treated and placebo groups, nor did any of the pointwise VF analyses.
Initial short-term VF changes in the treatment and placebo arms of UKGTS were the same. In these newly diagnosed patients with non-advanced glaucoma, we found no evidence to support the hypothesis that VF status improves after initial lowering of IOP by medical therapy.
关于眼压(IOP)降低治疗开始后视野(VF)状态能否改善这一假设的证据存在争议。我们利用英国青光眼治疗研究(UKGTS)的参与者入选数据,在随机接受降低眼压治疗或安慰剂治疗的新诊断青光眼患者中检验这一假设。
多中心、随机、三盲、安慰剂对照试验。
参与者为UKGTS中新诊断的开角型青光眼患者,有入选及基线数据(治疗组和安慰剂组分别有202名和205名参与者)。将UKGTS入选数据,包括两次可靠的视野检查(Humphrey 24-2 SITA标准)和眼压测量值,与分配至治疗组(局部使用前列腺素类似物)或安慰剂滴眼液后获得的UKGTS试验基线数据进行比较。在治疗组和安慰剂组中,比较此时间段内视野平均偏差(MD)的平均变化以及MD改善超过不同阈值的眼睛比例。次要分析包括按眼压水平、视野损失程度和年龄对组进行分层,以及包括视野位置子集变化的逐点分析。主要结局指标是视野MD的平均变化。
入选/基线访视与眼压降低之间的平均(标准差[SD])时间,治疗眼为12(3)周,治疗眼和安慰剂眼的眼压分别降低了4.8(4.2)mmHg和1.0(3.6)mmHg。治疗组(-0.03 [1.45] dB)和安慰剂组(+0.08 [1.72] dB;P = 0.47)的MD平均(SD)变化几乎相同。两组中MD改善1 dB或更多的参与者比例相似(P = 0.25)。未发现MD改善与眼压降低幅度之间存在关联。按眼压、视野损失程度和年龄对数据进行分层,未显示治疗组和安慰剂组之间存在任何差异,逐点视野分析也未发现差异。
UKGTS治疗组和安慰剂组最初的短期视野变化相同。在这些新诊断的非晚期青光眼患者中,我们没有发现证据支持眼压通过药物治疗初步降低后视野状态会改善这一假设。