The ROVO Study: Radial Optic Neurotomy for CVO
- Conditions
- Central Retinal Vein Occlusion
- Registration Number
- NCT00532142
- Lead Sponsor
- Rudolf Foundation Clinic
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
- 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)
-
• 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rudolf foundation Clinic
🇦🇹Vienna, Austria