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: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Participant)
- Drug: Intravitreal Triamcinolone
- Procedure: Radial Optic Neurotomy
- Other: Placebo – Sham Intravitreal Injection
Clinical Trial Outcome 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
- 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
- Lead Sponsor
- Rudolf Foundation Clinic
- Overall Official(s)
- Susanne Binder, M.D., Study Chair, no affiliation
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