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Study of Arterial Recanalization of the Central Retinal Artery Occlusions (RECANAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03049514
Recruitment Status : Recruiting
First Posted : February 10, 2017
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief 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.

Condition or disease
Central Retinal Artery Occlusion

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Study of Arterial Recanalization of the Central Retinal Artery Occlusions
Actual Study Start Date : December 23, 2016
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : February 2021



Primary Outcome Measures :
  1. Dynamic retinal angiography data at 24 hours (+/- 24 hours) [ Time Frame: 24 hours (+/- 24 hours) following the beginning of symptoms ]
    Proportion of patients with early arterial recanalization.The recanalization rate will be compared between thrombolysed patients and non-thrombolysed patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred for an central retinal artery occlusion
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03049514


Contacts
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Contact: Laurence Salomon, MD, PhD +33 148 036 431 lsalomon@for.paris

Locations
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France
Fondation ophtalmique Adolphe de Rothschild Recruiting
Paris, France, 75019
Contact: Laurence Salomon, MD, PhD    +33 1 48 03 64 31    lsalomon@for.paris   
Contact: Michaël Obadia, MD       mobadia@for.paris   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
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Principal Investigator: Michaël Obadia, MD Fondation A de Rothschild

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03049514    
Other Study ID Numbers: MOA_2016_22
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Thrombolysis
Recanalization
Dynamic retinal angiography
Additional relevant MeSH terms:
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Retinal Artery Occlusion
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Retinal Diseases
Eye Diseases