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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00379223
Recruitment Status : Terminated (lack of recruting)
First Posted : September 21, 2006
Last Update Posted : March 4, 2011
Information provided by:
University Hospital, Bordeaux

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Retinal Vein Occlusion Procedure: vitrectomy with radial optic neurotomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : October 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Efficacy [ Time Frame: between pre operative examination and 6 months after randomization ]
  2. Mean visual acuity [ Time Frame: between pre operative examination and 6 months ]
  3. Macular thickness in Optical Coherence Tomography (OCT)
  4. Persistence of hemorrhages in the fundus
  5. Retinal ischemia indicating pan retinal photocoagulation [ Time Frame: 6 months after randomization ]
  6. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00379223

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Service d'ophtalmologie, Hopital Pellegrin, place Amélie Raba Léon
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
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Principal Investigator: Jean François KOROBELNIK, Pr University Hospital, Bordeaux
Study Chair: Geneviève CHENE, pR University Hospital, Bordeaux

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Responsible Party: Jean Pierre LEROY/Clinical Research and innovation Director, University Hospital Bordeaux Identifier: NCT00379223     History of Changes
Other Study ID Numbers: 9418-04
First Posted: September 21, 2006    Key Record Dates
Last Update Posted: March 4, 2011
Last Verified: August 2008
Keywords provided by University Hospital, Bordeaux:
retinal vein occlusion
retinal disorders
vascular diseases
Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases