Clinical trial NCT02679716: 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
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Artery Occlusion
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Women in reproductive age

Primary outcomes:
measure: Pathological changes in subjects with retinal artery occlusions
timeFrame: one hour
Secondary outcomes:
measure: number of patients with preexisting stroke
timeFrame: one hour
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery
city: Vienna
country: Austria
facility: Hanusch-Krankenhaus
Study officials:
affiliation: Vienna Institute for Research in Ocular Surgery
name: Christoph Leisser, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vienna Institute for Research in Ocular Surgery
name: Oliver Findl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vienna Institute for Research in Ocular Surgery
name: Nino Hirnschall, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.