Skip to main content
OpenTrials
Completed

NCT Number: NCT00532142

The ROVO Study: Radial Optic Neurotomy for CVO

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Central Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Rudolf foundation Clinic

Vienna, State of Vienna, A1030, Austria

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intravitreal triamcinolone

Drug

Radial Optic Neurotomy

Procedure

Placebo - Sham Intravitreal Injection

Other

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Rudolf Foundation Clinic

Other

Registry information

Official study title

A Multicenter Trial for Surgical Treatment of Central Retinal Vein Occlusion - Radial Optic Neurotomy for CVO The ROVO Study

Important dates

Study start
2005
Study completion
2009
First posted
Sep 20, 2007
Registry last updated
Oct 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.