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
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2005
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 18, 2007
CompletedFirst Posted
Study publicly available on registry
September 20, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedOctober 30, 2009
October 1, 2009
September 18, 2007
October 29, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rudolf foundation Clinic
Vienna, Vienna, A1030, Austria
Related Publications (1)
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.
PMID: 22960949DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Susanne Binder, M.D.
no affiliation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 18, 2007
First Posted
September 20, 2007
Study Start
April 1, 2005
Study Completion
August 1, 2009
Last Updated
October 30, 2009
Record last verified: 2009-10