Half-Dose Photodynamic Therapy versus High-Density Subthreshold Micropulse Laser Treatment in Patients with Chronic Central Serous Chorioretinopathy The PLACE Trial

被引:251
作者
van Dijk, Elon H. C. [1 ]
Fauser, Sascha [2 ,3 ]
Breukink, Myrte B. [4 ]
Blanco-Garavito, Rocio [5 ]
Groenewoud, Joannes M. M. [6 ]
Keunen, Jan E. E. [4 ]
Peters, Petrus J. H. [7 ]
Dijkman, Greet [1 ]
Souied, Eric H. [5 ]
MacLaren, Robert E. [8 ]
Querques, Giuseppe [5 ,9 ]
Downes, Susan M. [8 ]
Hoyng, Carel B. [4 ]
Boon, Camiel J. F. [1 ,10 ]
机构
[1] Leiden Univ, Med Ctr, Dept Ophthalmol, POB 9600, NL-2300 RC Leiden, Netherlands
[2] Univ Hosp Cologne, Dept Ophthalmol, Cologne, Germany
[3] F Hoffmann La Roche, Basel, Switzerland
[4] Radboud Univ Nijmegen, Med Ctr, Dept Ophthalmol, Nijmegen, Netherlands
[5] Univ Paris Est Creteil, Ctr Hosp Intercommunal Creteil, Dept Ophthalmol, Creteil, France
[6] Radboud Univ Nijmegen, Med Ctr, Dept Hlth Evidence, Nijmegen, Netherlands
[7] Bergman Clin BV, Dept Ophthalmol, Velp, Netherlands
[8] John Radcliffe Hosp, Oxford Eye Hosp, Oxford, England
[9] Univ Vita Salute San Raffaele, IRCCS Osped San Raffaele, Dept Ophthalmol, Milan, Italy
[10] Univ Amsterdam, Acad Med Ctr, Dept Ophthalmol, Amsterdam, Netherlands
关键词
MACULAR DEGENERATION; CHOROIDAL NEOVASCULARIZATION; FOLLOW-UP; 577; NM; VERTEPORFIN; FLUENCE;
D O I
10.1016/j.ophtha.2018.04.021
中图分类号
R77 [眼科学];
学科分类号
100212 ;
摘要
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.
引用
收藏
页码:1547 / 1555
页数:9
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