The ROVO Study: Radial Optic Neurotomy for CVO

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3

Details

• Lead Sponsor: Rudolf Foundation Clinic
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

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.