Actively Recruiting
Early Reperfusion Therapy With Intravenous Thrombolysis for Recovery of VISION in Acute Central Retinal Artery Occlusion
Led by University Hospital Tuebingen · Updated on 2025-04-27
422
Participants Needed
1
Research Sites
220 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Non-arteritic, thromboembolic central retinal artery occlusion (CRAO) is an acute neurovascular-ophthalmological emergency which leads to severe and permanent vision loss; no evidence-based therapy does exist. Two recent meta-analyses indicate early intravenous thrombolysis to be beneficial in CRAO. Therefore, the REVISION randomized placebo-controlled interventional trial will investigate intravenous alteplase in CRAO as it is practiced in acute ischemic stroke, i.e. within 4.5 hours after symptom onset. The REVISION observational study will evaluate retinal changes on optical coherence tomography (OCT) in patients within 12 hours of CRAO onset, and the REVISION substudy, which will be conducted adjunct to either the interventional or the observational study, will evaluate the value of the retrobulbar spot sign for prediction of outcome and treatment response.
CONDITIONS
Official Title
Early Reperfusion Therapy With Intravenous Thrombolysis for Recovery of VISION in Acute Central Retinal Artery Occlusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute non-arteritic central retinal artery occlusion (CRAO) with sudden, painless vision loss in one eye within 12 hours of symptom onset confirmed by an ophthalmologist using several eye tests including OCT
- Visual acuity in the affected eye of LogMAR 1.3 or worse (functional blindness)
- Ability to read with the affected eye before CRAO (LogMAR 0.5 or better)
- Neurological examination done by an experienced stroke neurologist
- Brain imaging done by CT or MRI as part of acute retinal ischemia or stroke assessment
You will not qualify if you...
- Suspected giant cell arteritis
- Acute vision loss caused by conditions other than CRAO (such as retinal detachment, vitreous hemorrhage, acute glaucoma, or optic neuritis)
- Visual acuity better than LogMAR 1.3 or rapidly improving vision in the affected eye
- Presence of acute ischemic stroke needing intravenous thrombolysis
- Any co-existing or terminal illness with life expectancy less than 3 months
- Previous participation in the REVISION trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital Tuebingen
Tübingen, Germany, 72076
Actively Recruiting
Research Team
S
Sven Poli
CONTACT
J
Julia Zeller
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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