Elon H C van Dijk1, Sascha Fauser2, Myrte B Breukink3, Rocio Blanco-Garavito4, Joannes M M Groenewoud5, Jan E E Keunen3, Petrus J H Peters6, Greet Dijkman1, Eric H Souied4, Robert E MacLaren7, Giuseppe Querques8, Susan M Downes7, Carel B Hoyng3, Camiel J F Boon9. 1. Department of Ophthalmology, Leiden University Medical Center, Leiden, the Netherlands. 2. Department of Ophthalmology, University Hospital of Cologne, Cologne, Germany; F. Hoffmann-La Roche, Basel, Switzerland. 3. Department of Ophthalmology, Radboud University Medical Center, Nijmegen, the Netherlands. 4. Department of Ophthalmology, Centre Hospitalier Intercommunal de Creteil University Paris Est Creteil, Creteil, France. 5. Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands. 6. Department of Ophthalmology, Bergman Clinics B.V., Velp, the Netherlands. 7. Oxford Eye Hospital, John Radcliffe Hospital, Oxford, United Kingdom. 8. Department of Ophthalmology, Centre Hospitalier Intercommunal de Creteil University Paris Est Creteil, Creteil, France; Department of Ophthalmology, IRCCS Ospedale San Raffaele, Vita-Salute University, Milan, Italy. 9. Department of Ophthalmology, Leiden University Medical Center, Leiden, the Netherlands; Department of Ophthalmology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. Electronic address: c.j.f.boon@lumc.nl.
Abstract
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.
RCT Entities:
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.
Authors: Benedikt Schworm; Nikolaus Luft; Leonie F Keidel; Felix Hagenau; Christoph Kern; Tina Herold; Karsten U Kortuem; Siegfried G Priglinger; Jakob Siedlecki Journal: Graefes Arch Clin Exp Ophthalmol Date: 2020-02-28 Impact factor: 3.117