Study of Arterial Recanalization of the Central Retinal Artery Occlusions

Central Retinal Artery Occlusion Clinical Trial

— RECANAL  

Official title:

Study of Arterial Recanalization of the Central Retinal Artery Occlusions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03049514
• Other study ID #: MOA_2016_22
• Status: Completed
• Start date: December 23, 2016
• Est. completion date: April 2, 2022

Study information

• Verified date: April 2022
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Central retinal artery occlusions (CRAO) are the equivalent of an ischemic stroke (IS) at the retinal level. They share the same risk factors and common pathology. Their incidence is lower (8.5 / 100,000) and the functional prognosis is unfavorable in 80% of cases with visual acuity (VA) <1/10. The diagnosis of an CRAO is clinically based on the sudden occurrence of a decrease in deep visual acuity with fundamentally signs of reactive ischemia. There is no data on early retinal arterial recanalization after CRAO, nor on the relationship between early recanalization (spontaneous or post-thrombolysis) and visual prognosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2, 2022
• Est. primary completion date: April 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Central Retinal Artery Occlusion = 24 hours

Exclusion Criteria:

• Retinal Dynamic angiography not performed within 48 hours of onset of symptoms
• Occlusion of a branch of the central retinal artery

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Central Retinal Artery Occlusion
• Retinal Artery Occlusion

Locations

Country	Name	City	State
France	Fondation ophtalmique Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic retinal angiography data at 24 hours (+/- 24 hours)	Proportion of patients with early arterial recanalization.The recanalization rate will be compared between thrombolysed patients and non-thrombolysed patients	24 hours (+/- 24 hours) following the beginning of symptoms