The ROVO Study: Radial Optic Neurotomy for CVO

Central Retinal Vein Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00532142
• Other study ID #: EK-04-010-0204
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 18, 2007
• Last updated: October 29, 2009
• Start date: April 2005
• Est. completion date: August 2009

Study information

• Verified date: October 2009
• Source: Rudolf Foundation Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2009
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Retinal Vein Occlusion
• Retinal Vein Occlusion

Intervention

Drug:
• Intravitreal Triamcinolone

Procedure:
• Radial Optic Neurotomy

Other:
• Placebo - Sham Intravitreal Injection

Locations

Country	Name	City	State
Austria	Rudolf foundation Clinic	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Rudolf Foundation Clinic

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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