The ROVO Study: Radial Optic Neurotomy for CVO

Rudolf Foundation Clinic

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Central Retinal Vein Occlusion

Interventions

Intravitreal TriamcinoloneDRUG

Radial Optic NeurotomyPROCEDURE

Placebo - Sham Intravitreal InjectionOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Rudolf foundation Clinic

Vienna, State of Vienna, Austria

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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