Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05739487 |
Other study ID # |
XHEC-C-2022-057-1 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 1, 2020 |
Est. completion date |
March 31, 2022 |
Study information
Verified date |
February 2023 |
Source |
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
Description:
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. It is clinically significant to study the changes in visual fields in
eyes with CRAO. The short-term temporal changes (≤7-day) of VFDs and the adverse reactions in
eyes with CRAO after IAT were investigated to assess the efficacy and safety of the procedure
in this retrospective study.