PURPOSE To compare the anatomic and functional efficacy and safety of half-dose photodynamic therapy (PDT) versus high-density subthreshold micropulse laser (HSML) treatment in patients with chronic central serous chorioretinopathy (cCSC). DESIGN Open-label, multicenter, randomized controlled clinical trial. PARTICIPANTS Patients with cCSC whose disease had to be confirmed by both clinical characteristics and findings on multimodal imaging. METHODS Eligible patients were randomized in a 1:1 allocation ratio. Treatment was evaluated during a follow-up visit, and the same treatment was repeated in patients who still demonstrated subretinal fluid (SRF). MAIN OUTCOME MEASURES The primary end point was the complete disappearance of SRF at the first evaluation visit at 6 to 8 weeks after treatment. As a secondary outcome measure, we assessed this anatomic result at the final evaluation visit at 7 to 8 months after treatment. Other secondary outcomes covered functional improvement and included change in best-corrected visual acuity (BCVA; measured in Early Treatment Diabetic Retinopathy Study [ETDRS] letters), retinal sensitivity (measured using microperimetry), and vision-related quality of life using a validated questionnaire. RESULTS Between November 2013 and September 2016, 179 patients were included: 89 patients were assigned randomly to half-dose PDT, and 90 were assigned randomly to HSML treatment. At their first evaluation visit, SRF had resolved in 51.2% and 13.8% of patients, respectively (P < 0.001). At their final evaluation visit, a significantly higher percentage of PDT-treated patients demonstrated no SRF (67.2% vs. 28.8%; P < 0.001). Moreover, at the first evaluation visit, the PDT-treated patients showed a significantly higher increase in BCVA (+4.60±6.62 ETDRS letters vs. +1.39±8.99 ETDRS letters; P = 0.011), and a significantly higher increase in retinal sensitivity on microperimetry (+2.01±3.04 dB vs. +0.92±3.65 dB; P = 0.046); however, the improvement in vision-related quality of life was similar (score of +2.87±8.35 vs. +2.56±7.36, respectively; P = 0.800). CONCLUSIONS Half-dose PDT is superior to HSML for treating cCSC, leading to a significantly higher proportion of patients with complete resolution of SRF and functional improvement.

中文翻译：

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半剂量光动力疗法与高密度阈下微脉冲激光治疗慢性中心性浆液性脉络膜视网膜病变患者：PLACE 试验。


目的 比较半剂量光动力疗法 (PDT) 与高密度阈下微脉冲激光 (HSML) 治疗慢性中心性浆液性脉络膜视网膜病变 (cCSC) 患者的解剖学和功能疗效及安全性。设计 开放标签、多中心、随机对照临床试验。参与者 必须通过临床特征和多模态成像结果确认疾病的 cCSC 患者。方法 符合条件的患者按 1:1 的分配比例进行随机分配。在随访期间对治疗进行了评估，并对仍然表现出视网膜下液（SRF）的患者重复了相同的治疗。主要观察指标 主要终点是治疗后 6 至 8 周第一次评估时 SRF 完全消失。作为次要结果指标，我们在治疗后 7 至 8 个月的最终评估访视时评估了这一解剖结果。其他次要结局包括功能改善，包括最佳矫正视力（BCVA；在早期治疗糖尿病视网膜病变研究 [ETDRS] 字母中测量）、视网膜敏感性（使用微视野检查测量）以及使用经过验证的问卷的视力相关生活质量的变化。结果 2013年11月至2016年9月期间，纳入了179名患者：89名患者被随机分配接受半剂量PDT，90名患者被随机分配接受HSML治疗。在第一次评估访视时，SRF 分别在 51.2% 和 13.8% 的患者中得到缓解（P < 0.001）。在最终评估访视时，接受 PDT 治疗的患者中没有出现 SRF 的比例明显更高（67.2% 对比 28.8%；P < 0.001）。此外，在第一次评估访视时，接受 PDT 治疗的患者的 BCVA 表现出显着更高的增加（+4.60±6.0）。62 个 ETDRS 字母与 +1.39±8.99 个 ETDRS 字母； P = 0.011），显微视野检查的视网膜灵敏度显着提高（+2.01±3.04 dB vs. +0.92±3.65 dB；P = 0.046）；然而，视力相关生活质量的改善相似（得分分别为+2.87±8.35 和+2.56±7.36；P = 0.800）。结论 对于治疗 cCSC，半剂量 PDT 优于 HSML，导致 SRF 完全缓解和功能改善的患者比例明显更高。