An interventional study of vitrectomy with radial optic neurotomy in Retinal Vein Occlusion, sponsored by University Hospital, Bordeaux. Terminated at 1 site in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2011-03-04.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Treatment
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.
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.
282 studies on the registry are indexed under Retinal Vein Occlusion; 27 are open to participants now.
This study's enrollment of 7 is below the median of 49 across 211 interventional studies indexed under Retinal Vein Occlusion.
Browse Retinal Vein Occlusion studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
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Exclusion Criteria:
Standard treatment of central retinal vein occlusion : the rheologic correction
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
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
Efficacy
Time frame: between pre operative examination and 6 months after randomization
Mean visual acuity
Time frame: 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
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
This study is terminated, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux