NCT05562284

Safety and Efficacy After Selective Intra-arterial Thrombolysis for Central Retinal Artery Occlusion

Safety and Efficacy of the Visual Field Improvement After Selective Intra-arterial Thrombolysis for Central Retinal Artery Occlusion

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Central Retinal Artery Occlusion

Interventions

Type	Name	Description
PROCEDURE	intra-arterial thrombolysis	IAT introduces rt-PA directly into the ophthalmic circulation by super-selective microcatheterization.
OTHER	conservative treatments	conservative treatments

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-03-31
• Completion: 2024-03-31
• First posted: 2022-09-30
• Last updated: 2022-09-30

Locations

1 site across 1 country: China