Reconstruction of Pathological Changes of the Ophthalmic Artery in Patients With Retinal Artery Occlusion
Primary Purpose
Retinal Artery Occlusion
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
MRI of the cerebral arteries
Sponsored by
About this trial
This is an interventional screening trial for Retinal Artery Occlusion
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed RAO
- Older than 21 years
- Informed consent
Exclusion Criteria:
- Women in reproductive age
Sites / Locations
- Vienna Institute for Research in Ocular Surgery
- Hanusch-Krankenhaus
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
study group
Arm Description
MRI of the cerebral arteries ist performed
Outcomes
Primary Outcome Measures
Pathological changes in subjects with retinal artery occlusions
assessed by magnetic resonance imaging
Secondary Outcome Measures
number of patients with preexisting stroke
assessed by medical history and magnetic resonance imaging
Full Information
NCT ID
NCT02679716
First Posted
February 7, 2016
Last Updated
October 21, 2019
Sponsor
Vienna Institute for Research in Ocular Surgery
1. Study Identification
Unique Protocol Identification Number
NCT02679716
Brief Title
Reconstruction of Pathological Changes of the Ophthalmic Artery in Patients With Retinal Artery Occlusion
Official Title
Hemodynamic Computer-assisted Reconstruction of Pathological Changes at the Origin of the Ophthalmic Artery in Patients With Retinal Artery Occlusion
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
July 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Institute for Research in Ocular Surgery
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Artery Occlusion
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Other
Arm Description
MRI of the cerebral arteries ist performed
Intervention Type
Other
Intervention Name(s)
MRI of the cerebral arteries
Intervention Description
MRI of the cerebral arteries is performed
Primary Outcome Measure Information:
Title
Pathological changes in subjects with retinal artery occlusions
Description
assessed by magnetic resonance imaging
Time Frame
one hour
Secondary Outcome Measure Information:
Title
number of patients with preexisting stroke
Description
assessed by medical history and magnetic resonance imaging
Time Frame
one hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed RAO
Older than 21 years
Informed consent
Exclusion Criteria:
Women in reproductive age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Leisser, MD
Organizational Affiliation
Vienna Institute for Research in Ocular Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Oliver Findl, MD
Organizational Affiliation
Vienna Institute for Research in Ocular Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nino Hirnschall, MD
Organizational Affiliation
Vienna Institute for Research in Ocular Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
Hanusch-Krankenhaus
City
Vienna
ZIP/Postal Code
A-1140
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25500982
Citation
Leisser C, Kaufmann TA, Feltgen N, Schumacher M, Schmoor C, Meckel S. Distribution of internal carotid artery plaque locations among patients with central retinal artery occlusion in the Eagle study population. Graefes Arch Clin Exp Ophthalmol. 2015 Aug;253(8):1227-30. doi: 10.1007/s00417-014-2804-2. Epub 2014 Dec 13.
Results Reference
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PubMed Identifier
12364725
Citation
Mead GE, Lewis SC, Wardlaw JM, Dennis MS. Comparison of risk factors in patients with transient and prolonged eye and brain ischemic syndromes. Stroke. 2002 Oct;33(10):2383-90. doi: 10.1161/01.str.0000029827.93497.97.
Results Reference
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PubMed Identifier
19577305
Citation
Hayreh SS, Podhajsky PA, Zimmerman MB. Retinal artery occlusion: associated systemic and ophthalmic abnormalities. Ophthalmology. 2009 Oct;116(10):1928-36. doi: 10.1016/j.ophtha.2009.03.006. Epub 2009 Jul 3.
Results Reference
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PubMed Identifier
24503410
Citation
Lee J, Kim SW, Lee SC, Kwon OW, Kim YD, Byeon SH. Co-occurrence of acute retinal artery occlusion and acute ischemic stroke: diffusion-weighted magnetic resonance imaging study. Am J Ophthalmol. 2014 Jun;157(6):1231-8. doi: 10.1016/j.ajo.2014.01.033. Epub 2014 Feb 4.
Results Reference
background
PubMed Identifier
22809785
Citation
Chang YS, Jan RL, Weng SF, Wang JJ, Chio CC, Wei FT, Chu CC. Retinal artery occlusion and the 3-year risk of stroke in Taiwan: a nationwide population-based study. Am J Ophthalmol. 2012 Oct;154(4):645-652.e1. doi: 10.1016/j.ajo.2012.03.046. Epub 2012 Jul 17.
Results Reference
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Reconstruction of Pathological Changes of the Ophthalmic Artery in Patients With Retinal Artery Occlusion
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