Clinical trial NCT00379223: Radial Optic Neurotomy in Central Retinal Vein Occlusion : a Randomized Trial
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Retinal Vein Occlusion
Keywords: retinal vein occlusion
vitrectomy
surgery
retinal disorders
vascular diseases
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2006-09-21
Enrollment: 7
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Efficacy
timeFrame: between pre operative examination and 6 months after randomization
measure: Mean visual acuity
timeFrame: between pre operative examination and 6 months
measure: Macular thickness in Optical Coherence Tomography (OCT)
measure: Persistence of hemorrhages in the fundus
measure: Retinal ischemia indicating pan retinal photocoagulation
timeFrame: 6 months after randomization
measure: Safety : Serious complications after surgery (retinal detachment, retinal ischemia, neovascular glaucoma) or medical treatment during the 6 months following surgery.
timeFrame: after surgery or medical treatment examination and 6 months after randomization
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service d'ophtalmologie, Hopital Pellegrin, place Amélie Raba Léon
Study officials:
affiliation: University Hospital, Bordeaux
name: Jean François KOROBELNIK, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Geneviève CHENE, pR
role: STUDY_CHAIR
References: