An interventional study of intra-arterial thrombolysis and conservative treatments in Central Retinal Artery Occlusion, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-30.
Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Treatment
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.
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. The respective responses of brain and retinal tissues to acute ischemia share many features is the rationale for therapeutic thrombolysis in CRAO. Intravenous thrombolysis (IVT) has been a therapeutic choice for CRAO since the 1960s, and in the United States, tPA is currently administered in 5.8% of patients admitted with CRAO. 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 which has the advantage of reducing the dose of rt-PA reaching the systemic circulation. Thus, IAT 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. Sequential evaluation by Humphrey perimetry will evaluate the temporal changes before and after IAT or conservative therapies. Our study will enroll patients within 7 days of symptom onset and aims at evaluating the safety of IAT and comparing the improvement of the VFDs between conservative treatments and IAT combined with conservative treatments.
31 studies on the registry are indexed under Retinal Artery Occlusion; 6 are open to participants now.
This study's planned enrollment of 128 is above the median of 58 across 18 interventional studies indexed under Retinal Artery Occlusion.
Browse Retinal Artery Occlusion studies →Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 225 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
Ocular factor or disease
Systemic factors restricting thrombolysis
IAT (Drug: 50 mg Alteplase)+conservative treatments
Procedure: intra-arterial thrombolysis · Other: conservative treatments
conservative treatments including traditional ones and hyperbaric oxygen therapy
Other: conservative treatments
IAT introduces rt-PA directly into the ophthalmic circulation by super-selective microcatheterization.
conservative treatments
Change of the visual field index as mean deviation (MD) examed by Humphrey visual field analyzer at 3 months
Change of the mean deviation
Time frame: 90 days
Change of the visual field index as visual field index (VFI) examed by Humphrey visual field analyzer at 3 months
Change of the visual field index
Time frame: 90 days
Change of Best corrected visual acuity (BCVA) at 3 months
best corrected visual acuity of logarithm of the minimum angle of resolution
Time frame: 90 days
Adverse reactions at 1 month
Death, symptomatic or asymptomatic intracranial hemorrhage, intraocular hemorrhage
Time frame: 30 days
Plan to share: Yes — protocols
Supporting information: Study protocol
Time frame: 90 days after the interventions
Access criteria: if required propriately
No publications or documents are linked to this record.
Started Jun 2022 (actual). Primary completion is estimated for Mar 2024, 21 months after the start.
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This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine →