Radial Optic Neurotomy in Central Retinal Vein Occlusion : a Randomized Trial (OVCR)

March 3, 2011 updated by: University Hospital, Bordeaux

Multicenter Trial to Investigate the Safety and Efficacy of Vitrectomy With Radial Optic Neurotomy for the Preservation of Visual Function in Subjects With Central Retinal Vein Occlusion (CRVO)

Natural evolution of severe central retinal vein occlusion with low visual acuity is very poor. A randomized clinical trial will compare troxerutin and platelet anti-aggregating agents (drug treatment) versus surgery and drug treatment. Surgery will include vitrectomy and radial optic neurotomy. The primary outcome will be vision measured 6 months after surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Central Retinal Vein Occlusion (CRVO) is the second most frequently retinal vascular disease causing loss of vision, after diabetic retinopathy. No treatment of CRVO has clearly demonstrated beneficial and long lasting visual results. Commonly used treatment options are platelet anti-aggregating agents, correcting rheologic factors with troxerutin and isovolumic hemodilution. Surgical treatment of CRVO has recently been proposed (2001) and has been studied in numerous non comparative pilot studies. Limited but encouraging results motivate our randomised controlled trial. We will evaluate at 6 months visual acuity after surgery associating pars plana vitrectomy and radial optic neurotomy, in patients with central vein occlusion and bad vision, associated with the correction of rheologic factors.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Service d'ophtalmologie, Hopital Pellegrin, place Amélie Raba Léon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Central Retinal Vein Occlusion oedematous or hemorrhagic (at fundus exam and at fluorescein angiography)
  • Visual Acuity (VA) ≤ 20/200 with ETDRS charts
  • Decreased VA since more than 1 month, less than 3 months
  • Common care recommendations for CRVO during the period before recruitment (Control ocular pressure if associated hypertension or glaucoma ; Hemodilution if hematocrit ≥ 38% ,if no cardio-vascular contra-indication, to maintain hematocrit under 38% during 6 weeks ; Troxerutin (3 /d) and aspirin (100 - 160 mg/d) ; Clinical and angiographic controls to look for retinal ischemia indicating laser PRP to prevent neovascular glaucoma.
  • Signed informed consent.

Exclusion Criteria:

  • Ischemic CRVO : 1- More than 30 disc diameters of ischemia at fluorescein angiography and/or •2- If Angiogram is uninterpretable because of hemorrhages, deficit of afferent pupillary reflex 0.9 with photographic filters (proposed by Hayreh) with indication to do laser PRP or laser PRP already done,
  • Rubeosis or neovascular glaucoma,
  • Bilateral diabetic retinopathy preproliferative or proliferative,
  • Uncharacterized coagulation disease, or anticoagulant treatment,
  • Untreated systemic disease (diabetes, severe high blood pressure, Cardiac failure) ou eye disease (glaucoma),
  • Contra-indication or documented allergy to troxerutin or platelet anti-aggregating agents,
  • Contra-indication to surgical procedure
  • incapacity to received an informed consent, incapacity to follow all the study schedule

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
Standard treatment of central retinal vein occlusion : the rheologic correction
Experimental: 2
Standard treatment of central retinal vein occlusion : the rheologic correction and surgery associating pars plana vitrectomy and radial optic neurotomy
Procedure: vitrectomy with radial optic neurotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients showing an improvement of visual acuity (at least 3 lines (15 letters) in ETDRS charts)
Time Frame: between pre operative examination and 6 months after randomization
between pre operative examination and 6 months after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy
Time Frame: between pre operative examination and 6 months after randomization
between pre operative examination and 6 months after randomization
Mean visual acuity
Time Frame: between pre operative examination and 6 months
between pre operative examination and 6 months
Macular thickness in Optical Coherence Tomography (OCT)
Persistence of hemorrhages in the fundus
Retinal ischemia indicating pan retinal photocoagulation
Time Frame: 6 months after randomization
6 months after randomization
Safety : Serious complications after surgery (retinal detachment, retinal ischemia, neovascular glaucoma) or medical treatment during the 6 months following surgery.
Time Frame: after surgery or medical treatment examination and 6 months after randomization
after surgery or medical treatment examination and 6 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Study Chair: Geneviève CHENE, Pr, University Hospital, Bordeaux
  • Principal Investigator: Jean François KOROBELNIK, Pr, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

September 20, 2006

First Submitted That Met QC Criteria

September 20, 2006

First Posted (Estimate)

September 21, 2006

Study Record Updates

Last Update Posted (Estimate)

March 4, 2011

Last Update Submitted That Met QC Criteria

March 3, 2011

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9418-04
  • 2004-028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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