Viewing Study NCT05739487



Ignite Creation Date: 2024-05-06 @ 6:38 PM
Last Modification Date: 2024-10-26 @ 2:52 PM
Study NCT ID: NCT05739487
Status: COMPLETED
Last Update Posted: 2023-02-22
First Post: 2023-02-13

Brief Title: Changes of Visual Field Defects After IAT for CRAO
Sponsor: Xinhua Hospital Shanghai Jiao Tong University School of Medicine
Organization: Xinhua Hospital Shanghai Jiao Tong University School of Medicine

Study Overview

Official Title: Changes of Visual Field Defects After Selective Intra-arterial Thrombolysis for Central Retinal Artery Occlusion
Status: COMPLETED
Status Verified Date: 2023-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed 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 58 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None