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The ROVO Study: Radial Optic Neurotomy for CVO

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00532142
Recruitment Status : Completed
First Posted : September 20, 2007
Last Update Posted : October 30, 2009
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
Central Retinal Vein Occlusion Drug: Intravitreal Triamcinolone Procedure: Radial Optic Neurotomy Other: Placebo - Sham Intravitreal Injection Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Multicenter Trial for Surgical Treatment of Central Retinal Vein Occlusion - Radial Optic Neurotomy for CVO The ROVO Study
Study Start Date : April 2005
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00532142


Locations
Austria
Rudolf foundation Clinic
Vienna, Austria, A1030
Sponsors and Collaborators
Rudolf Foundation Clinic
Investigators
Study Chair: Susanne Binder, M.D. no affiliation
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00532142     History of Changes
Other Study ID Numbers: EK-04-010-0204
First Posted: September 20, 2007    Key Record Dates
Last Update Posted: October 30, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action