Safety and Efficacy After Selective Intra-arterial Thrombolysis for Central Retinal Artery Occlusion (NCT05562284) | Clinical Trial Compass
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Safety and Efficacy After Selective Intra-arterial Thrombolysis for Central Retinal Artery Occlusion
China128 participantsStarted 2022-06-01
Plain-language summary
Central retinal artery occlusion (CRAO) is an ophthalmic emergency which leads to devastating visual function defects and poor prognosis. Though traditional conservative treatments are widely used, none of them is proved to be effective. A number of meta-analyses and observational studies indicate intravenous thrombolysis to be beneficial in CRAO. Selective intra-arterial thrombolysis (IAT) introducing rt-PA directly into the ophthalmic circulation by super-selective microcatheterization may reduce the complications such as intracranial and systemic hemorrhage.The residual visual field is significant for patients with CRAO who have poor central visual acuity. Thus, it is clinically significant to study the changes in visual fields in eyes with CRAO.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Non-arteritic CRAO with symptom duration ≤7d
✓. Age from 18 years old between 80 years old
✓. Qualified systemic conditions, well-controlled blood pressure, well-controlled blood glucose, qualified liver and kidney function, no allergic history to contrast agent or rt-PA,
✓. Meet the inclusion of HBOT
Exclusion criteria
✕. Branch retinal artery occlusion
✕. Combined retinal vein occlusion
✕. Suspicious ocular ischemic syndrome, such as ophthalmic artery occlusion or carotid artery occlusion
✕. Existed retinal problems decreasing visual function, such as macular disease, severe nonproliferative or proliferative diabetic retinopathy, severe cataract or glaucoma
✕. Central retinal artery occlusion from iatrogenic cause
✕
What they're measuring
1
Change of the visual field index as mean deviation (MD) examed by Humphrey visual field analyzer at 3 months
Timeframe: 90 days
2
Change of the visual field index as visual field index (VFI) examed by Humphrey visual field analyzer at 3 months
Timeframe: 90 days
Trial details
NCT IDNCT05562284
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine