A Multicenter Trial for Surgical Treatment of Central Retinal Vein Occlusion - Radial Optic Neurotomy for CVO The ROVO Study
| Registry | NCT00532142 |
|---|---|
| Status | Completed |
| Phase | Phase 2 / Phase 3 |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Sponsor | Rudolf Foundation Clinic (Other) |
| Conditions | Central Retinal Vein Occlusion |
| Interventions | Intravitreal Triamcinolone, Radial Optic Neurotomy, Placebo - Sham Intravitreal Injection (Drug, procedure, other) |
| Dates | start 2005-04-01, completion 2009-08-01, first posted 2007-09-20, last updated 2009-10-30 |
| Locations | 1 site in Austria |
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All trials for Central Retinal Vein Occlusion All trials of Intravitreal Triamcinolone All trials of Radial Optic Neurotomy
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.
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Rudolf foundation Clinic | Vienna, State of Vienna | Austria |