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Vitrectomy with and without encircling band for pseudophakic retinal detachment: VIPER Study Report No 2—main results
  1. Peter Walter1,
  2. Martin Hellmich2,
  3. Sabine Baumgarten1,
  4. Petra Schiller2,
  5. Endrik Limburg3,
  6. Hansjürgen Agostini4,
  7. Amelie Pielen4,5,
  8. Horst Helbig6,
  9. Albrecht Lommatzsch7,
  10. Gernot Rössler1,
  11. Babac Mazinani1
  12. for the VIPER Study Group
    1. 1Department of Ophthalmology, RWTH Aachen University, Aachen, Germany
    2. 2Institute of Medical Statistics, Informatics and Epidemiology, University of Cologne, Cologne, Germany
    3. 3Clinical Trials Centre Cologne (CTCC), University of Cologne, Cologne, Germany
    4. 4Eye Center, Albert-Ludwigs-University of Freiburg, Freiburg, Germany
    5. 5Eye Hospital, Hannover Medical School, Hannover, Germany
    6. 6Department of Ophthalmology, University of Regensburg, Regensburg, Germany
    7. 7Department of Ophthalmology, Franziskus Hospital, Münster, Germany
    1. Correspondence to Dr Babac Mazinani, Department of Ophthalmology, RWTH Aachen University, Pauwelsstr. 30, Aachen 52074, Germany; bmazinani{at}gmx.de

    Abstract

    Background It is unclear whether or not an additional encircling band improves outcome in vitrectomy for pseudophakic retinal detachment (PRD). Also unclear is whether small gauge transconjunctival trocar-guided vitrectomy is as successful as conventional 20 gauge (G) vitrectomy.

    Methods 257 adult patients with uncomplicated PRD were enrolled in 14 vitreoretinal centres across Germany. Contingent on availability of qualified surgeons, eligible patients were randomly assigned either (i) with ratio 1:1 to 20 G vitrectomy plus encircling band (group E1) or 20 G vitrectomy without any buckle (group C) or (ii) with ratios 1:1:1 to group E1, C or 23/25 G vitrectomy without any buckle (group E2). Treatment success was defined as no indication for any retina reattaching procedure during the follow-up of 6 months.

    Results Success was reached in 79.0% (=79/100, group E1) versus 73.5% (=72/98, group C) (p=0.558, OR 1.32, 95% CI 0.65 to 2.65. In group E2 87.7% (=50/57) of patients reached success compared with 78.7% (=48/61) in group C, demonstrating non-inferiority of E2 to C regarding the prespecified margin of 0.8 (OR scale; p=0.05, OR 2.17, 95% CI 0.80 to 5.89). Best corrected visual acuity significantly increased after surgery independent of technique, that is, on average −0.7 (from 1.0 to 0.3) logMAR. Patients suffered from a shift in spherical refraction of −1.0 D in group E1 compared with −0.1 D in group C. Similarly, intraoperative complications (15.2% vs 8.8% of patients) and serious adverse events (30.3% vs 22.5% of patients) were more frequent in group E1.

    Conclusions Vitrectomy with gas is an efficient and safe treatment for uncomplicated PRD. An additional encircling band does not significantly reduce the risk for any second procedure necessary to reattach the retina in 20 G vitrectomy. Small gauge transconjunctival vitrectomy is not inferior to the conventional 20 G technique.

    Trial registration number DKRS 00003158, Results.

    • Retina
    • Treatment Surgery

    This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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