The ROVO Study: Radial Optic Neurotomy for CVO

A Multicenter Trial for Surgical Treatment of Central Retinal Vein Occlusion - Radial Optic Neurotomy for CVO The ROVO Study

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00532142

Enrollment

Unknown

Registered

2007-09-20

Start date

2005-04-30

Completion date

2009-08-31

Last updated

2009-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Retinal Vein Occlusion

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.

Interventions

DRUGIntravitreal Triamcinolone

PROCEDURERadial Optic Neurotomy

OTHERPlacebo - Sham Intravitreal Injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026