Fibrinolysis, Hemodilution, Retinal Artery Occlusion, Stroke, Visual Acuity
Conditions
Brief summary
The aim of the EAGLE Study is to compare the efficacy of conservative medical treatment and local intraarterial fibrinolysis in patients with central retinal artery occlusion and to evaluate benefit and risk for the patient of both therapies.
Interventions
DRUGIntravenous injection of heparin
DRUGIntravenous injection of acetazolamide
PROCEDURELocal intra-arterial fibrinolysis
PROCEDUREGlobe massage
DRUGTopical use of beta-blocker
DRUGIsovolaemic haemodilution
DRUGAcetylsalicylic acid
Sponsors
Boehringer Ingelheim
University Hospital Freiburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subtotal central retinal artery occlusion or central retinal artery occlusion with choroidal hypoperfusion not lasting longer than 20h * Patients aged from 18 years to 75 years (in case of pre-existing blindness of other eye also older than 75 years) * Informed consent of the patient
Exclusion criteria
* Central retinal artery occlusion lasting longer than 20h * Eye diseases, namely branch retinal artery occlusion, cilioretinal arteries supplying the macula, combined arterial-venous occlusion, proliferative diabetic retinopathy and elevated intraocular pressure (over 30 mmHg) * Systemic diseases, namely severe general diseases, systemic arterial hypertension (systolic pressure \> 200 mmHg), despite medical therapy, acute systemic inflammation (erythrocyte sedimentation rate \> 30 mm within the first hour/ C-reactive protein \> 1,0 mg/dl), antithrombin-III deficiency in case of thrombocytopenia (\< 100000 per ml): pathologic clotting time, acute pancreatitis with elevated pancreas enzymes * Medical History: heart attack within the last 6 weeks, intracerebral bleeding or neurosurgical operation within the last 4 weeks, therapy with marcumar/warfarin, allergic reaction to contrast agent, haemorrhagic diathesis, aneurysms, inflammatory vascular diseases (e.g., giant cell arteritis, Wegener´s granulomatosis), endocarditis, gastric ulcer * Patient participation in other studies during the prior 4 weeks * No willingness and ability of the patient to participate in all follow-up examinations * Pregnancy * Written consent not given * Patient is not mobile (bedridden) * Other conditions/ circumstances likely to lead to poor treatment adherence (e.g., history of poor compliance, alcohol or drug dependency, no fixed abode)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual acuity 1 month after therapy in comparison with visual acuity before therapy measured according to ETDRS Scale. | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of visual field | 1 month |
| Effect on retinal circulation | 1 month |
| Tolerance of therapies and registration of number, form and severity of complications | 1 month |
| Evaluation of prognostic factors | — |
Countries
Austria, Germany, Switzerland
Outcome results
None listed