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A prospective, randomised, multicenter trial for surgical treatment of central retinal vein occlusion: results of the Radial Optic Neurotomy for Central Vein Occlusion (ROVO) study group

  • Retinal Disorders
  • Published:
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Abstract

Background

To compare the surgical outcomes and evaluate the effectiveness of two treatments for central retinal vein occlusion (CRVO), radial optic neurotomy (RON) and intravitreal triamcinolone (IVT), in comparison to natural history.

Methods

A prospective, placebo-controlled, randomised and multi-center study. Patients with CRVO were treated in three groups — with either RON, a single intravitreal injection of 4 mg triamcinolone acetonide, or a placebo treatment. The main outcome measures were change of VA (visual acuity) and proportion of eyes with a significant improvement (defined as >3 lines logMAR scale) of VA from baseline to month 12.

Results

Ninety patients were included. Due to insufficient data, seven were excluded. Forty-seven percent (n = 18) of patients treated with RON showed an increase in VA, in comparison to 10 % (n = 2) of placebo-treated patients, and 20 % (n = 5) of patients treated with IVT. Significantly more patients showed an improvement in VA following RON than in the placebo group (p = 0.009). Significantly more patients showed an improvement in VA following RON than in the IVT group (p = 0.034). No significant difference was found when directly comparing improvement in VA following IVT and placebo (p = 0.667) treatment.Significantly (p = 0.007) more patients in the placebo group (35 %, n = 7) showed a deterioration (defined as > 3 lines LogMAR scale) in VA than patients in the RON group (8 %, n = 3).

Conclusion

Our study showed that following treatment with RON, patients with CRVO display a significantly better long-term VA than untreated patients and patients treated with a single dose of IVT.

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Acknowledgments

The authors thank the principal investigators in The ROVO Study Group:

Prof. Dr. Michel Eid Farah — Universidade Federal de São Paulo, Brazil

Prof. Dr. Vito Belloli — Ospedale S.S. Trinità di Arona, Italy

Prof. Dr. António Travassos — Centro Cirúrgico de Coimbra, Portugal

Prof. Dr. Marta Suárez de Figueroa — Ramón y Cajal University Hospital, Spain

Prof. Dr. José Garcia-Arumi — Instituto de Microcirugía Ocular, Spain

Prof. Dr. Tarapasad Das — LV Prasad Eye Institute, India

The authors also thank the entire staff of all participating centers and all helpers who contributed towards this study, especially Prof. Dr. Wolfgang Radner, Prof. Dr. Peter Bauer, Prof. Dr. Siamak Ansari Shahrezaei, Ms. Astrid Kürsten and the entire staff of the Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery, Vienna, Austria.

The study was financed by a grant from the Jubiläumsfonds der Österreichischen Nationalbank (OeNB)) /Austrian National Bank, as well as by the Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery, Vienna, Austria.

The authors have no commercial connection or financial interest that is related to the manuscript. The authors have full control of all primary data, and agree to allow Graefe's Archive for Clinical and Experimental Ophthalmology to review their data upon request.

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Authors and Affiliations

  1. Department of Ophthalmology, Rudolf Foundation Clinic, Juchgasse 25, 1030, Vienna, Austria

    Tina Aggermann, Simon Brunner, Ilse Krebs, Paulina Haas & Susanne Binder

  2. The Ludwig Boltzmann Institute for Retinology and Biomicroscopic Laser Surgery, Vienna, Austria

    Tina Aggermann, Simon Brunner, Ilse Krebs, Paulina Haas & Susanne Binder

  3. Institute for Medical Statistics, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria

    Irene Womastek & Werner Brannath

Authors
  1. Tina Aggermann
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  2. Simon Brunner
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  3. Ilse Krebs
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  4. Paulina Haas
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  5. Irene Womastek
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  6. Werner Brannath
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  7. Susanne Binder
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Consortia

The ROVO Study Group

Corresponding author

Correspondence to Tina Aggermann.

Additional information

The ROVO Study Group:

Prof. Dr. Susanne Binder - Rudolph Foundation Hospital, Austria Prof. Dr. Michel Eid Farah — Universidade Federal de São Paulo, Brazil Prof. Dr. Vito Belloli — Ospedale S.S. Trinità di Arona, Italy Prof. Dr. António Travassos — Centro Cirúrgico de Coimbra, Portugal Prof. Dr. Marta Suárez de Figueroa — Ramón y Cajal University Hospital, Spain Prof. Dr. José Garcia-Arumi — Instituto de Microcirugía Ocular, Spain Prof. Dr. Tarapasad Das — LV Prasad Eye Institute, India

Clinical trial registration

EK-04-010-0204 NCT00532142 http://www.clinicaltrials.gov

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Aggermann, T., Brunner, S., Krebs, I. et al. A prospective, randomised, multicenter trial for surgical treatment of central retinal vein occlusion: results of the Radial Optic Neurotomy for Central Vein Occlusion (ROVO) study group. Graefes Arch Clin Exp Ophthalmol 251, 1065–1072 (2013). https://doi.org/10.1007/s00417-012-2134-1

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  • DOI: https://doi.org/10.1007/s00417-012-2134-1

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