期刊
OPHTHALMOLOGY
卷 125, 期 10, 页码 1547-1555出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.ophtha.2018.04.021
关键词
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资金
- Stichting Macula Fonds
- Retina Nederland Onderzoek Fonds
- Stichting Blinden-Penning
- Algemene Nederlandse Vereniging ter Voorkoming van Blindheid
- Landelijke Stichting voor Blinden en Slechtzienden through UitZicht (Delft, the Netherlands)
- Rotterdamse Stichting Blindenbelangen (Rotterdam, the Netherlands)
- Stichting Leids Oogheelkundig Ondersteuningsfonds (Leiden, the Netherlands)
- Haagse Stichting Blindenhulp (The Hague, the Netherlands)
- Stichting Ooglijders (Rotterdam, the Netherlands)
- Oxford NIHR Biomedical Research Center (Oxford, United Kingdom)
- Gisela Thier Fellowship of Leiden University, Leiden, the Netherlands
- Netherlands Organisation for Scientific Research (VENI grant)
- Novartis Pharma B.V. (Arnhem, the Netherlands)
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. (C) 2018 by the American Academy of Ophthalmology.
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