Status:
TERMINATED
Radial Optic Neurotomy in Central Retinal Vein Occlusion : a Randomized Trial
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Retinal Vein Occlusion
Eligibility:
All Genders
50+ years
Phase:
NA
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...
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 beneficia...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00379223
Start Date
October 1 2006
End Date
September 1 2008
Last Update
March 4 2011
Active Locations (1)
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1
Service d'ophtalmologie, Hopital Pellegrin, place Amélie Raba Léon
Bordeaux, France, 33076