Universität zu Köln

Mazinani, B., Baumgarten, S., Schiller, P., Agostini, H., Helbig, H., Limburg, E., Hellmich, M. and Walter, P. (2016). Vitrectomy with or without encircling band for pseudophakic retinal detachment: a multi-centre, three-arm, randomised clinical trial. VIPER Study Report No. 1-design and enrolment. Br. J. Ophthalmol., 100 (3). S. 405 - 411. LONDON: BMJ PUBLISHING GROUP. ISSN 1468-2079

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Abstract

Purpose Scleral buckling is currently used in addition to vitrectomy for the treatment of pseudophakic retinal detachment (PRD) to better support the vitreous base and better visualisation of the periphery. Aims The aims of this study are to evaluate (1) whether the combination of 20 G vitrectomy and scleral buckling is superior to 20 G vitrectomy alone (control) (confirmatory), and (2) whether transconjunctival 23/25 G vitrectomy is non-inferior to 20 G vitrectomy (both without scleral buckling) regarding operation success (exploratory). Methods The VIPER (Vitrectomy Plus Encircling Band Vs. Vitrectomy Alone For The Treatment Of Pseudophakic Retinal Detachment) study is an unmasked, multi-centre, three-arm randomised trial. Patients with PRD were eligible, excluding complicated retinal detachment or otherwise severe ophthalmologic impairment. Patients were randomised to one of three interventions: 20 G vitrectomy alone (control C), combination of 20 G vitrectomy and circumferential scleral buckling (experimental treatment E1) or 23/25 G vitrectomy alone (experimental treatment E2). The primary endpoint is the absence of any indication for a retina re-attaching procedure during 6 months of follow-up. Secondary endpoints include best corrected visual acuity, retina re-attaching procedures, complications and adverse events. Results From June 2011 to August 2013, 257 patients were enrolled in the study. The internet randomisation service assigned 100 patients each to the treatment arms C and E1, and 57 patients to treatment E2. The imbalance is due to the fact that several retinal surgeons did not qualify for performing E2. The random assignment was stratified and balanced (ie, 1:1 or 1:1:1 ratio) by surgeon. Conclusions The described study represents a methodologically rigorous protocol evaluating the benefits of three different vitrectomy approaches to PRD. The projected results will help to establish their overall efficacy and will permit conclusions regarding their relative value.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Mazinani, B. UNSPECIFIED UNSPECIFIED UNSPECIFIED Baumgarten, S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Schiller, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Agostini, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Helbig, H. UNSPECIFIED UNSPECIFIED UNSPECIFIED Limburg, E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hellmich, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Walter, P. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-283307
DOI:	10.1136/bjophthalmol-2015-306732
Journal or Publication Title:	Br. J. Ophthalmol.
Volume:	100
Number:	3
Page Range:	S. 405 - 411
Date:	2016
Publisher:	BMJ PUBLISHING GROUP
Place of Publication:	LONDON
ISSN:	1468-2079
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language PARS-PLANA VITRECTOMY; 20-GAUGE VITRECTOMY; 25-GAUGE; REPAIR; BREAK Multiple languages Ophthalmology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/28330