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The ROVO Study: Radial Optic Neurotomy for CVO

Primary Purpose

Central Retinal Vein Occlusion

Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Intravitreal Triamcinolone
Radial Optic Neurotomy
Placebo - Sham Intravitreal Injection
Sponsored by
Rudolf Foundation Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Retinal Vein Occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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.

Sites / Locations

  • Rudolf foundation Clinic

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 18, 2007
Last Updated
October 29, 2009
Sponsor
Rudolf Foundation Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00532142
Brief Title
The ROVO Study: Radial Optic Neurotomy for CVO
Official Title
A Multicenter Trial for Surgical Treatment of Central Retinal Vein Occlusion - Radial Optic Neurotomy for CVO The ROVO Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rudolf Foundation Clinic

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Retinal Vein Occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Intravitreal Triamcinolone
Intervention Type
Procedure
Intervention Name(s)
Radial Optic Neurotomy
Intervention Type
Other
Intervention Name(s)
Placebo - Sham Intravitreal Injection
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Binder, M.D.
Organizational Affiliation
no affiliation
Official's Role
Study Chair
Facility Information:
Facility Name
Rudolf foundation Clinic
City
Vienna
ZIP/Postal Code
A1030
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
22960949
Citation
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.
Results Reference
derived

Learn more about this trial

The ROVO Study: Radial Optic Neurotomy for CVO

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