Text Size

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
History of Changes

September 18, 2007
October 29, 2009
April 2005
Not Provided
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
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Not Provided
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
Not Provided
August 2009
Not Provided

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
Not Provided
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00532142
EK-04-010-0204
No
Not Provided
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