Trial | NCT00532142  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    triamcinolone ...

  • Study Participants

    None
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.
Study Started
Apr 30
2005
Study Completion
Aug 31
2009
Last Update
Oct 30
2009
Estimate

Drug Intravitreal Triamcinolone

Procedure Radial Optic Neurotomy

Other Placebo - Sham Intravitreal Injection

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.
No Results Posted