The ROVO Study: Radial Optic Neurotomy for CVO

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.

Full Title of Study: “A Multicenter Trial for Surgical Treatment of Central Retinal Vein Occlusion – Radial Optic Neurotomy for CVO The ROVO Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)

Interventions

  • Drug: Intravitreal Triamcinolone
  • Procedure: Radial Optic Neurotomy
  • Other: Placebo – Sham Intravitreal Injection

Clinical Trial Outcome Measures

Primary 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Rudolf Foundation Clinic
  • Overall Official(s)
    • Susanne Binder, M.D., Study Chair, no affiliation

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