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

Sponsor
Vienna Institute for Research in Ocular Surgery (Other)
Overall Status
Completed
CT.gov ID
NCT02679716
Collaborator
(none)
30
2
1
44
15
0.3

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: MRI of the cerebral arteries
N/A

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.

Study Design

Study Type:
Interventional
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 :
Dec 1, 2014
Actual Primary Completion Date :
Jul 31, 2017
Actual Study Completion Date :
Jul 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: study group

MRI of the cerebral arteries ist performed

Other: MRI of the cerebral arteries
MRI of the cerebral arteries is performed

Outcome Measures

Primary Outcome Measures

  1. Pathological changes in subjects with retinal artery occlusions [one hour]

    assessed by magnetic resonance imaging

Secondary Outcome Measures

  1. number of patients with preexisting stroke [one hour]

    assessed by medical history and magnetic resonance imaging

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Newly diagnosed RAO

  • Older than 21 years

  • Informed consent

Exclusion Criteria:
  • Women in reproductive age

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vienna Institute for Research in Ocular Surgery Vienna Austria 1140
2 Hanusch-Krankenhaus Vienna Austria A-1140

Sponsors and Collaborators

  • Vienna Institute for Research in Ocular Surgery

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

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:
Feb 10, 2016
Last Update Posted:
Oct 22, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 22, 2019