The ROVO Study: Radial Optic Neurotomy for CVO

Rudolf Foundation Clinic

Status and phase

Completed

Phase 3

Phase 2

Conditions

Central Retinal Vein Occlusion

Treatments

Procedure: Radial Optic Neurotomy

Drug: Intravitreal Triamcinolone

Other: Placebo - Sham Intravitreal Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT00532142

EK-04-010-0204

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.