The ROVO Study: Radial Optic Neurotomy for CVO

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Central Retinal Vein Occlusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intravitreal Triamcinolone

Intervention Type DRUG

Radial Optic Neurotomy

Intervention Type PROCEDURE

Placebo - Sham Intravitreal Injection

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Susanne Binder, M.D.

Role: STUDY_CHAIR

no affiliation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rudolf foundation Clinic

Vienna, Vienna, Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

References

Explore related publications, articles, or registry entries linked to this study.

Aggermann T, Brunner S, Krebs I, Haas P, Womastek I, Brannath W, Binder S; ROVO Study Group. A prospective, randomised, multicenter trial for surgical treatment of central retinal vein occlusion: results of the Radial Optic Neurotomy for Central Vein Occlusion (ROVO) study group. Graefes Arch Clin Exp Ophthalmol. 2013 Apr;251(4):1065-72. doi: 10.1007/s00417-012-2134-1. Epub 2012 Sep 8.

Reference Type DERIVED

PMID: 22960949 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EK-04-010-0204

Identifier Type: -

Identifier Source: org_study_id