一项 577nm 亚阈微脉冲激光与半剂量光动力疗法治疗急性中心性浆液性脉络膜视网膜病变的随机非劣效性试验。

A randomized non-inferiority trial of 577nm subthreshold micropulse laser versus half-dose photodynamic therapy for acute central serous chorioretinopathy.

机构信息

State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, 54 South Xianlie Road, Guangzhou 510060, China.

State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, 54 South Xianlie Road, Guangzhou 510060, China; Sun Yat-sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.

出版信息

Photodiagnosis Photodyn Ther. 2024 Feb;45:103908. doi: 10.1016/j.pdpdt.2023.103908. Epub 2023 Nov 23.

DOI:10.1016/j.pdpdt.2023.103908

PMID:38007036

Abstract

PURPOSE

To compare the effectiveness of 577nm subthreshold micropulse laser (SML) with half-dose photodynamic therapy (Hd-PDT) for acute central serous chorioretinopathy (CSC).

METHOD

A non-inferiority clinical trial was performed with a non-inferiority margin of eight letters. Sixty-eight eyes of 68 patients with acute CSC were randomized to the Hd-PDT group or 577 nm SML group. Best-corrected visual acuity (BCVA ), the subretinal fluid (SRF), and the central foveal thickness (CFT) were evaluated at 6 months.

RESULTS

The visual acuity significantly improved from 70.38 ± 10.37 at baseline to 83.24 ± 3.03 at 6 months after treatment in the SML group (P < 0.001), from 71.09 ± 10.50 to 84.35 ± 2.09 in the PDT group (P < 0.001). SML was non-inferior to the PDT (mean difference: -0.41, 95% CI: -5.51 - 4.68, P = 0.0021). At the endpoint, CFT was significantly reduced in the two groups, but no statistical difference (P = 0.7694). The complete resolution of SRF reached 82.35% (28/34) in the SML group and 91.18% (31/34) in the PDT group, respectively,but no statistical difference (P = 0.3724).

CONCLUSIONS

SML was non-inferiority to half-dose PDT in improving the visual acuity for CSC, and it is a viable alternative, especially when the verteporfin in PDT is unavailable.

摘要

目的

比较 577nm 亚阈微脉冲激光（SML）与半剂量光动力疗法（Hd-PDT）治疗急性中心性浆液性脉络膜视网膜病变（CSC）的疗效。

方法

采用非劣效性临床试验设计，非劣效性边界为 8 个字母。将 68 例 68 只眼急性 CSC 患者随机分为 Hd-PDT 组和 577nm SML 组。分别于治疗后 6 个月评估最佳矫正视力（BCVA）、视网膜下液（SRF）和中心凹视网膜厚度（CFT）。

结果

SML 组治疗后 BCVA 从基线时的 70.38±10.37 提高到 6 个月时的 83.24±3.03（P<0.001），PDT 组从 71.09±10.50 提高到 84.35±2.09（P<0.001）。SML 与 PDT 相比非劣效（平均差值：-0.41，95%CI：-5.51~4.68，P=0.0021）。两组在终点时 CFT 均显著降低，但无统计学差异（P=0.7694）。SML 组 SRF 完全吸收率为 82.35%（28/34），PDT 组为 91.18%（31/34），但无统计学差异（P=0.3724）。