Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Shatin, Hong Kong.
Department of Ophthalmology, Hong Kong Eye Hospital, Kowloon City, Hong Kong.
Br J Ophthalmol. 2021 Apr;105(4):514-520. doi: 10.1136/bjophthalmol-2020-316178. Epub 2020 Jun 30.
To compare the intraocular pressure (IOP) lowering effect and safety profile between pattern scanning laser trabeculoplasty (PSLT) and selective laser trabeculoplasty (SLT) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) over a 12-month follow-up.
132 patients with POAG or OHT were consecutively enrolled and randomised (1:1) to receive PSLT (n=65) or SLT (n=67) in a single centre. IOP was measured before and then on 1 day, 1 week, 1, 3, 6, 9 and 12 months after PSLT/SLT. The primary outcome measure was the proportion of patients with ≥20% IOP reduction at 12 months without IOP-lowering medications (complete success).
The mean baseline IOP was 21.2±4.1 mm Hg for eyes randomised to PSLT and 21.3±4.7 mm Hg for eyes randomised to SLT (p=0.898). At 12 months, the IOP was 18.3±3.1 and 17.8±3.4 mm Hg, respectively (p=0.402). IOP measurements were comparable between the groups over 12 months (overall mean difference 0.4 mm Hg, 95% CI: -0.5 to 1.3 mm Hg). 15.4% of PSLT-treated and 25.4% of SLT-treated patients achieved treatment success (difference: 10.0%, 95% CI: -3.6 to 23.6) (p=0.155), respectively. A higher baseline IOP and a greater percentage of IOP reduction at day 1 were associated with a greater percentage of IOP reduction at 12 months (p<0.001). There were no significant differences in visual field mean deviation, average retinal nerve fibre layer thickness, corneal endothelial cell count and visual acuity between the treatment groups at the baseline and 12-month follow-up (p≥0.062).
PSLT was not superior to SLT in terms of safety and IOP-lowering efficacy in patients with POAG or OHT.
The clinical trial was registered in the Centre for Research and Biostatistics Clinical Trials Registry, the Chinese University of Hong Kong (Identifier CUHK_CCT00407). The full trial protocol can be accessed from the authors on request.
比较原发性开角型青光眼（POAG）或高眼压症（OHT）患者接受模式扫描激光小梁成形术（PSLT）和选择性激光小梁成形术（SLT）治疗后 12 个月的眼压（IOP）降低效果和安全性。
连续纳入 132 例 POAG 或 OHT 患者，并在单一中心以 1:1 的比例随机（PSLT：n=65；SLT：n=67）接受 PSLT 或 SLT 治疗。PSLT/SLT 治疗后第 1、7、1、3、6、9 和 12 天测量 IOP，在基线和 12 个月后进行。主要结局指标为 12 个月内不使用降眼压药物时 IOP 降低≥20%的患者比例（完全成功）。
PSLT 组和 SLT 组的平均基线 IOP 分别为 21.2±4.1mmHg 和 21.3±4.7mmHg（p=0.898）。12 个月时，IOP 分别为 18.3±3.1mmHg 和 17.8±3.4mmHg（p=0.402）。两组在 12 个月时的 IOP 测量值相当（总体平均差异 0.4mmHg，95%CI：-0.5 至 1.3mmHg）。PSLT 治疗组 15.4%和 SLT 治疗组 25.4%的患者达到治疗成功（差异：10.0%，95%CI：-3.6 至 23.6）（p=0.155）。基线时较高的 IOP 和第 1 天更高的 IOP 降低百分比与 12 个月时更高的 IOP 降低百分比相关（p<0.001）。治疗组在基线和 12 个月随访时的平均视野缺损、平均视网膜神经纤维层厚度、角膜内皮细胞计数和视力均无显著差异（p≥0.062）。
在 POAG 或 OHT 患者中，PSLT 在安全性和降低 IOP 方面并不优于 SLT。
该临床试验在中国香港中文大学研究与生物统计学临床试验注册中心注册（注册号：CUHK_CCT00407）。作者可根据要求提供完整的试验方案。
