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

Not Applicable

Completed

• Conditions: Retinal Artery Occlusion
• Interventions: Other: MRI of the cerebral arteries

• Registration Number: NCT02679716
• Lead Sponsor: 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

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 Timeline

• Study Start: 2014-12
• Study First Submitted: 2016-02-07
• Study First Submitted QC: 2016-02-07
• Study First Posted: 2016-02-10
• Primary Completion: 2017-07-31
• Study Completion: 2018-07-31
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• Women in reproductive age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
study group	MRI of the cerebral arteries	MRI of the cerebral arteries ist performed

Primary Outcome Measures

Name	Time	Method
Pathological changes in subjects with retinal artery occlusions	one hour	assessed by magnetic resonance imaging

Secondary Outcome Measures

Name	Time	Method
number of patients with preexisting stroke	one hour	assessed by medical history and magnetic resonance imaging

Trial Locations

Locations (2)

Vienna Institute for Research in Ocular Surgery; 🇦🇹 Vienna, Austria

Hanusch-Krankenhaus; 🇦🇹 Vienna, Austria