Clinical Trial: Reconstruction of Pathological Changes of the Ophthalmic Artery in Patients With Retinal Artery Occlusion
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Hemodynamic Computer-assisted Reconstruction of Pathological Changes at the Origin of the Ophthalmic Artery in Patients With Retinal Artery Occlusion
Brief Summary:
Retinal artery occlusions (RAO) cause deterioration in visual acuity and visual fields. In computational fluid dynamics (CFD) studies [Kaufmann et al. 2012] 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 [Wang et al 2006, Leisser et al 2010-2014], there is a discrepancy between CFD-studies and clinical observations. Mead et al. [7] 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. 2002).
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 Summary:
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 [Kaufmann et al. 2012] 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 [Wang et al 2006, Leisser et al 2010-2014], there is a discrepancy between CFD-studies and clinical observations. Mead et al. [7] 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. (2009) 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. 2002). A recently published report showed ischemic cerebral lesions in 38% of patients with RAO without neurological symptoms [Lee et al. 2014]. The fact, that the 3-year risk of patients with RAO to develop stroke is doubled [Chang et al. 2012], 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
Sponsor: Vienna Institute for Research in Ocular Surgery
Current Primary Outcome: Pathological changes in subjects with retinal artery occlusions [ Time Frame: one hour ]
Original Primary Outcome: Same as current
Current Secondary Outcome: number of patients with preexisting stroke [ Time Frame: one hour ]
Original Secondary Outcome: Same as current
Information By: Vienna Institute for Research in Ocular Surgery
Dates:
Date Received: February 7, 2016
Date Started: December 2014
Date Completion: July 2017
Last Updated: November 8, 2016
Last Verified: November 2016
