Radial Optic Neurotomy in Central Retinal Vein Occlusion : a Randomized Trial (NCT00379223) | Clinical Trial Compass
TerminatedNot Applicable
Radial Optic Neurotomy in Central Retinal Vein Occlusion : a Randomized Trial
Stopped: lack of recruting
France7 participantsStarted 2006-10
Plain-language 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.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 fo…
What they're measuring
1
Proportion of patients showing an improvement of visual acuity (at least 3 lines (15 letters) in ETDRS charts)
Timeframe: between pre operative examination and 6 months after randomization