Viewing Study NCT02679716



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Last Modification Date: 2024-10-26 @ 11:57 AM
Study NCT ID: NCT02679716
Status: COMPLETED
Last Update Posted: 2019-10-22
First Post: 2016-02-07

Brief Title: Reconstruction of Pathological Changes of the Ophthalmic Artery in Patients With Retinal Artery Occlusion
Sponsor: Vienna Institute for Research in Ocular Surgery
Organization: Vienna Institute for Research in Ocular Surgery

Study Overview

Official Title: Hemodynamic Computer-assisted Reconstruction of Pathological Changes at the Origin of the Ophthalmic Artery in Patients With Retinal Artery Occlusion
Status: COMPLETED
Status Verified Date: 2019-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 al2

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 al2 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None