None listed
Conditions
Brief summary
Central retinal artery occlusion (CRAO) is an eye Stroke, usually caused by the blood vessel supplying the eye being blocked, resulting in the eye not working. Usually, once the eye stroke occurs, the vision in the eye is severely affected and recovery is minimal. Unfortunately, most standard treatments at the moment do not improve vision. On average, most patient are not able to see the biggest letter on the eye chart out of the affected eye after the eye stroke. Some centres overseas have looked at using the medication used in heart attack (tPA) in eye stroke using a procedure to deliver the medication to the blocked blood vessel. The results are preliminary but promising. Most of the studies delivers the drug through an invasive procedure to deliver the medication close to where the blood vessel blockage is near the eye. Another way to deliver the medication is through a drip. This is the method for treatment in acute stroke of the brain when people present within a certain time window. This study aims to see if admininstration of the medication through a drip may improve the vision in acute eye stroke yet reducing the side effects of bleeing.
Interventions
Intravenous infusion of tissue plasimonogen activator (tPA) versus standard therapy
Tissue plasminogen activator will be given at dosage of 0.9mg/kg in 100ml of normal saline over 1 hour. Standard therapy group will be given placebo therapy of Normal saline 100ml over 1 hour. The therapy will be randomised in a 1:1 ratio using a block randomization schedule. The infusion will be covered in black cover for masking.
Sponsors
Flinders Medical Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: 1. Age greater than or equal to 18 years old 2. Acute central retinal artery occluasion (CRAO) within 24 hours of onset of symptoms (ie within 24hours of last know time with normal vision) 3. A presumed thromboembolic cause 4. No evidence of temporal arteritis by clinical assessment or laboratory studies (e.g., erythrocyte sedimentation rate [ESR]) 5. Non-contrast computerized tomography (CT) brain demonstrating no acute intra-cranial haemorrhage, infarction or mass lesion 6. Computerized tomography angiography (CTA) demonstrating no ipsilateral carotid artery occlusion.
Exclusion criteria
-Uncertain time of CRAO onset -A current or previous history of systemic hemorrhage within the last 12 months -Computerised tomography (CT) of the brain showing evidence of intracranial hemorrhage -Clinical evidence of CRAO from giant cell arteritis -Inability to obtain subject consent -Clinical, biochemical or imaging predictors of increased risk of intracerebral hemorrhage including : o Brain CT shwoing early ischemic changes of greater 1/3 of the middle cerebral artery territory o Brian CT showing an arterial hyperdensity on proximal internal carotid artery o Major surgery or serious trauma in the last 2 weeks o Gastrointestinal or urinary bleeding within 3 weeks o Arterial puncture or lumbar puncture within the 7 days. o A platelet count of <100 o Heparin administered within the last 48 hours or vitamin K antagonist for an INR of >1.7 o Age >80 o Systolic blood pressure of >185 and diastolic blood pressure of >110 o A glycaemic value >400mg/dl (22.22mmol/L)
Outcome results
None listed