The ROVO Study: Radial Optic Neurotomy for CVO

This study has been completed.
Sponsor:
Information provided by:
Rudolf Foundation Clinic
ClinicalTrials.gov Identifier:
NCT00532142
First received: September 18, 2007
Last updated: October 29, 2009
Last verified: October 2009

September 18, 2007
October 29, 2009
April 2005
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Proportion of eyes with an improvement of more than 15 letters (approximately > 3 lines of visual acuity gain) after one year as compared to baseline
Same as current
Complete list of historical versions of study NCT00532142 on ClinicalTrials.gov Archive Site
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The ROVO Study: Radial Optic Neurotomy for CVO
A Multicenter Trial for Surgical Treatment of Central Retinal Vein Occlusion - Radial Optic Neurotomy for CVO The ROVO Study

The ROVO study is a prospective, placebocontrolled and randomised study designed to evaluate the effect of radial optic neurotomy in central vein occlusion, versus triamcinolone acetonide. 240 patients with a visual acuity < 0.5 Snellen will be randomised. Patients are treated with either RON, or a single intravitreal injection of 4 mg triamcinolone acetonide, or a placebo treatment - a "sham" injection of intravitreal triamcinolone. Patients will be examined regularly over a period of one year.

Best corrected visual acuity for far and near, as well as clinical examinations, fluorescein- and indocyanine green angiograms, optical coherence tomography, and perimetry, are performed pre- and postoperatively.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Central Retinal Vein Occlusion
  • Drug: Intravitreal Triamcinolone
  • Procedure: Radial Optic Neurotomy
  • Other: Placebo - Sham Intravitreal Injection
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Aggermann T, Brunner S, Krebs I, Haas P, Womastek I, Brannath W, Binder S; ROVO Study Group. 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. 2013 Apr;251(4):1065-72. doi: 10.1007/s00417-012-2134-1. Epub 2012 Sep 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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August 2009
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Inclusion Criteria:

  • Onset of CVO not longer than 12 months
  • On FLA 1. nonperfused - (greater than 10 disc area of nonperfusion) 2. perfused - visual acuity lower than 0.1 Snellen,or 3. perfused with no improvement of visual acuity over 4 weeks)

Exclusion Criteria:

  • • Dense cataract* (grade 3 and 4) which precludes judgement of the fundus.

    • Pregnancy
    • Allergy against Fluoresceine or Indocyanine green
    • Unable to come for follow up visit
    • Presence of other severe retinopathy or
    • Presence of advanced optic atrophy or uncontrolled glaucoma.
    • Visual acuity higher than 0.5 Snellen.
Both
18 Years and older
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Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00532142
EK-04-010-0204
No
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Rudolf Foundation Clinic
Not Provided
Study Chair: Susanne Binder, M.D. no affiliation
Rudolf Foundation Clinic
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP