Optic Nerve Diseases Clinical Trial
Official title:
Erythropoietin in Methanol Associated Optic Neuropathy
Methanol poisoning could result in severe optic neuropathy, profound visual loss and finally
optic atrophy and permanent, irreversible optic atrophy and visual loss. Erythropoietin (EPO)
has recently emerged as a drug that may help retinal ganglion cell loss and improve optic
nerve function in some acquired types of optic neuropathy including traumatic optic
neuropathy ,ischemic optic neuropathy and optic neuritis .It has been found that EPO offer
some protection to the optic nerve and retina when they are injured and apoptosis process
starts in retinal ganglion cells. The standard treatments of methanol poisoning are
reanimation, metabolic stabilization, and inhibition of alcohol dehydrogenase by antagonist
agents and elimination of toxic metabolites in early phase of toxicity by dialysis. However,
after established optic neuropathy and visual loss there is little chance, if any, for visual
recovery and no definitive treatment exist for treatment in these cases. The investigators
recently reported the investigators preliminary results on 16 cases with methanol poisoning
and found a beneficial effect of systemic erythropoietin in methanol associated optic
neuropathy. Now, the investigators aim to investigate the effect of this agent in a clinical
trial.
The purpose of this study is to determine if EPO could improves optic nerve function and help
patients to improve visual recovery after methanol poisoning. Primary outcome measure would
be best-corrected visual function and secondary outcome measure is ocular coherence
tomography (OCT) measure of mean peripapillary nerve fiber layer thickness. Results of this
study could be very valuable in formulating an evidence-based management of Methanol
Associated Optic Neuropathy(MAON) and provide a high level evidence for changing the practice
on management of methanol poisoning . Also it could provide valuable data for neuroprotective
effects of erythropoietin specifically in neuroscience and ophthalmology.
The EPO-MAON trial is designed as a randomized, controlled, observer, and interpreter blinded
mono-center pilot trial with two parallel groups and a primary endpoint of best corrected
visual acuity during 120 days after enrollment into treatment groups.
All patients with methanol poisoning referred to Farabi hospital will be examined and
evaluated for best-corrected visual acuity, pupillary light reflexes, relative afferent
pupillary defect, color vision (Ishihara plates), fundus photography, slit lamp exam of
anterior segment and fundus exam with 78 D lens.
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