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Reconstruction of Pathological Changes of the Ophthalmic Artery in Patients With Retinal Artery Occlusion

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ClinicalTrials.gov Identifier: NCT02679716
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery

Brief Summary:

Retinal artery occlusions (RAO) cause deterioration in visual acuity and visual fields. In computational fluid dynamics (CFD) studies [1] 10% of ascending emboli caused RAO, the residual 90% embolized into the cerebral arteries. As only 20% of patients with RAO had a history of stroke, there is a discrepancy between CFD-studies and clinical observations. Mead et al. [2] postulated small emboli being washed into the cerebral arteries without causing clinical symptoms of stroke, whereas similar emboli being washed into the ophthalmic artery would cause RAO.

There is a discrepancy between CFD-study results and clinical observations in RAO patients, indicating that there could be a high number of RAO-patients having had cerebral ischemies without symptoms of stroke (as postulated by Mead et al.[2]).

Purpose of the present study is to evaluate hemodynamic pathological changes at the ophthalmic artery origin in patients with RAO detected with an already existing CFD-model


Condition or disease Intervention/treatment Phase
Retinal Artery Occlusion Other: MRI of the cerebral arteries Not Applicable

Detailed Description:

Retinal artery occlusions (RAO) cause deterioration in visual acuity and visual fields. Emboli from plaques of the carotid artery, aortic arch or vegetations of the cardiac valves are the main reasons for RAO. In computational fluid dynamics (CFD) studies [1] 10% of ascending emboli caused RAO, the residual 90% embolized into the cerebral arteries. As only 20% of patients with RAO had a history of stroke, there is a discrepancy between CFD-studies and clinical observations. Mead et al. [2] postulated small emboli being washed into the cerebral arteries without causing clinical symptoms of stroke, whereas similar emboli being washed into the ophthalmic artery would cause RAO. Hayreh et al. [3] reported plaques of the carotid artery to be the main reason for emboli causing RAO.

There is a discrepancy between CFD-study results and clinical observations in RAO patients, indicating that there could be a high number of RAO-patients having had cerebral ischemies without symptoms of stroke (as postulated by Mead et al.[2]). A recently published report showed ischemic cerebral lesions in 38% of patients with RAO without neurological symptoms [4]. The fact, that the 3-year risk of patients with RAO to develop stroke is doubled [5], underlines further associations between RAO and stroke.

Purpose of the present study is to evaluate hemodynamic pathological changes at the ophthalmic artery origin in patients with RAO detected with an already existing CFD-model

References (detailed references are provided in the reference section) :

[1] Leisser et al., [2] Mead et al., [3] Hayreh et al., [4] Lee et al., [5] Chang et al.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Hemodynamic Computer-assisted Reconstruction of Pathological Changes at the Origin of the Ophthalmic Artery in Patients With Retinal Artery Occlusion
Study Start Date : December 2014
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2018

Arm Intervention/treatment
study group
MRI of the cerebral arteries ist performed
Other: MRI of the cerebral arteries
MRI of the cerebral arteries is performed




Primary Outcome Measures :
  1. Pathological changes in subjects with retinal artery occlusions [ Time Frame: one hour ]
    assessed by magnetic resonance imaging


Secondary Outcome Measures :
  1. number of patients with preexisting stroke [ Time Frame: one hour ]
    assessed by medical history and magnetic resonance imaging



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed RAO
  • Older than 21 years
  • Informed consent

Exclusion Criteria:

  • Women in reproductive age

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): NCT02679716


Locations
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Austria
Vienna Institute for Research in Ocular Surgery
Vienna, Austria, 1140
Hanusch-Krankenhaus
Vienna, Austria, A-1140
Sponsors and Collaborators
Vienna Institute for Research in Ocular Surgery
Investigators
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Principal Investigator: Christoph Leisser, MD Vienna Institute for Research in Ocular Surgery
Principal Investigator: Oliver Findl, MD Vienna Institute for Research in Ocular Surgery
Principal Investigator: Nino Hirnschall, MD Vienna Institute for Research in Ocular Surgery
Publications:
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Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier: NCT02679716    
Other Study ID Numbers: RAO
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Retinal Artery Occlusion
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Retinal Diseases
Eye Diseases