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CompletedNCT00532142Updated Oct 30, 2009

The ROVO Study: Radial Optic Neurotomy for CVO

A Phase 2/3 interventional study of Intravitreal Triamcinolone and Radial Optic Neurotomy in Central Retinal Vein Occlusion, sponsored by Rudolf Foundation Clinic. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-10-30.

Sponsored by Rudolf Foundation Clinic · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Central Retinal Vein Occlusion
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In context

Retinal Vein Occlusion

282 studies on the registry are indexed under Retinal Vein Occlusion; 27 are open to participants now.

Browse Retinal Vein Occlusion studies →

Lead sponsor

Rudolf Foundation Clinic is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

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

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.
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)

Interventions

  • DrugIntravitreal Triamcinolone
  • ProcedureRadial Optic Neurotomy
  • OtherPlacebo - Sham Intravitreal Injection
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What researchers measure

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

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Study locations

1 site
  • Rudolf foundation Clinic
    Vienna, A1030, Austria
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References and documents

Publications

  • 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. PubMed 22960949 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00532142
Lead sponsor
Rudolf Foundation Clinic
First posted
Sep 20, 2007
Start date
Apr 2005
Completion
Aug 2009
Last update
Oct 30, 2009

Study contacts

Susanne Binder, M.D.
study chair · no affiliation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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