Half-Dose Photodynamic Therapy versus High-Density Subthreshold Micropulse Laser Treatment in Patients with Chronic Central Serous Chorioretinopathy: The PLACE Trial
Publication year
2018Source
Ophthalmology, 125, 10, (2018), pp. 1547-1555ISSN
Publication type
Article / Letter to editor

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Organization
Ophthalmology
Health Evidence
Journal title
Ophthalmology
Volume
vol. 125
Issue
iss. 10
Page start
p. 1547
Page end
p. 1555
Subject
Radboudumc 12: Sensory disorders DCMN: Donders Center for Medical Neuroscience; Radboudumc 13: Stress-related disorders DCMN: Donders Center for Medical NeuroscienceAbstract
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.
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