Universität zu Köln

Breukink, Myrte B., Downes, Susan M., Querques, Giuseppe ORCID: 0000-0002-3292-9581, van Dijk, Elon H. C., den Hollander, Anneke I., Blanco-Garavito, Rocio, Keunen, Jan E. E., Souied, Eric H., MacLaren, Robert E., Hoyng, Carel B., Fauser, Sascha and Boon, Camiel J. F. (2015). Comparing half-dose photodynamic therapy with high-density subthreshold micropulse laser treatment in patients with chronic central serous chorioretinopathy (the PLACE trial): study protocol for a randomized controlled trial. Trials, 16. LONDON: BMC. ISSN 1745-6215

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Abstract

Background: Chronic central serous chorioretinopathy (cCSC) is an eye disease characterized by an accumulation of serous fluid under the retina. It is postulated that this fluid accumulation results from hyperpermeability and swelling of the choroid, the underlying vascular tissue of the eye, causing a dysfunction of the retinal pigment epithelium. This fluid accumulation causes neuroretinal detachment. A prolonged neuroretinal detachment in the macula can lead to permanent vision loss. Therefore, treatment is aimed primarily at achieving resolution of subretinal fluid, preferably within the first 4 months after diagnosis of the disease. A broad spectrum of treatment modalities has been investigated in cCSC, but no consensus exists on the optimal treatment of cCSC. Currently, photodynamic therapy (PDT) and high-density subthreshold micropulse laser treatment (HSML) are among the most frequently cited treatments in obtaining successful neuroretinal reattachment. Methods/Design: This is a randomized, controlled, open-label, multicenter trial comparing the efficacy of half-dose PDT to HSML in treating patients with cCSC. A total of 156 patients will be recruited, 78 patients in each treatment arm, with a maximum follow-up duration of 8 months after the first treatment. A complete ophthalmological examination with vision-related quality of life (NEI VFQ-25) and stress questionnaires, will be performed at baseline, 6 to 8 weeks after the first treatment, 6 to 8 weeks after a second treatment (if necessary), and at the final follow-up visit at 7 to 8 months after the first treatment. Treatment visits will be scheduled within 3 weeks after the baseline visit, and within 3 weeks after the first control visit, if a second treatment is required. Discussion: Both half-dose PDT and HSML may be effective treatments in cCSC, but because of the lack of prospective randomized controlled trials, which treatment should be the first choice remains unclear. The aim of this study is to compare the efficacy of half-dose PDT to HSML. The primary endpoint to evaluate efficacy will be a complete absence of subretinal fluid on optical coherence tomography after treatment. Secondary functional endpoints include change in Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity, retinal sensitivity on microperimetry, and NEI VFQ-25 questionnaire of visual functioning. Registration number Institutional Review Board (CMO Arnhem-Nijmegen, the Netherlands): 2013/203 NL nr.: 41266.091.13

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Breukink, Myrte B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Downes, Susan M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Querques, Giuseppe UNSPECIFIED orcid.org/0000-0002-3292-9581 UNSPECIFIED van Dijk, Elon H. C. UNSPECIFIED UNSPECIFIED UNSPECIFIED den Hollander, Anneke I. UNSPECIFIED UNSPECIFIED UNSPECIFIED Blanco-Garavito, Rocio UNSPECIFIED UNSPECIFIED UNSPECIFIED Keunen, Jan E. E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Souied, Eric H. UNSPECIFIED UNSPECIFIED UNSPECIFIED MacLaren, Robert E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hoyng, Carel B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Fauser, Sascha UNSPECIFIED UNSPECIFIED UNSPECIFIED Boon, Camiel J. F. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-392805
DOI:	10.1186/s13063-015-0939-z
Journal or Publication Title:	Trials
Volume:	16
Date:	2015
Publisher:	BMC
Place of Publication:	LONDON
ISSN:	1745-6215
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language TERM FOLLOW-UP; RETINAL-PIGMENT EPITHELIOPATHY; OPTICAL COHERENCE TOMOGRAPHY; MACULAR DEGENERATION; CHOROIDAL THICKNESS; VERTEPORFIN PDT; VISUAL-ACUITY; HUMAN EYES; PHOTOCOAGULATION; UPDATE Multiple languages Medicine, Research & Experimental Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/39280