title: 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.
abstract: OBJECTIVE
  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.
  
  
  OBJECTIVE
  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.
  
  
  BACKGROUND
  DRKS00003158 (German Clinical Trials Register, DRKS).
authors.affiliation: Department of Ophthalmology, RWTH Aachen University, Aachen, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Mazinani
authors.affiliation: Department of Ophthalmology, RWTH Aachen University, Aachen, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Baumgarten
authors.affiliation: Institute of Medical Statistics, Informatics and Epidemiology (IMSIE), University of Cologne, Köln, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Schiller
authors.affiliation: Eye Center, Albert-Ludwigs-University, Freiburg, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Agostini
authors.affiliation: Department of Ophthalmology, University Hospital Regensburg, Regensburg, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Helbig
authors.affiliation: Clinical Trials Center Cologne (ZKS), University of Cologne, Köln, Germany.
authors.forename: E
authors.initials: E
authors.lastname: Limburg
authors.affiliation: Institute of Medical Statistics, Informatics and Epidemiology (IMSIE), University of Cologne, Köln, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Hellmich
authors.affiliation: Department of Ophthalmology, RWTH Aachen University, Aachen, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Walter
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D008297:Male; D018579:Patient Selection; D011446:Prospective Studies; D019591:Pseudophakia / Q000503:physiopathology / Q000601:surgery*; D012107:Research Design; D012160:Retina / Q000502:physiology; D012163:Retinal Detachment / Q000503:physiopathology / Q000601:surgery*; D012591:Scleral Buckling; D014792:Visual Acuity / Q000502:physiology; D014821:Vitrectomy
keywords: Retina; Treatment Surgery