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, 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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