NCT02679716

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

October 22, 2019

Status Verified

October 1, 2019

Enrollment Period

2.7 years

First QC Date

February 7, 2016

Last Update Submit

October 21, 2019

Conditions

Retinal Artery Occlusion

Outcome Measures

Primary Outcomes (1)

  • Pathological changes in subjects with retinal artery occlusions

    assessed by magnetic resonance imaging

    one hour

Secondary Outcomes (1)

  • number of patients with preexisting stroke

    one hour

Study Arms (1)

study group

OTHER

MRI of the cerebral arteries ist performed

Other: MRI of the cerebral arteries

Interventions

MRI of the cerebral arteriesOTHER

MRI of the cerebral arteries is performed

study group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Women in reproductive age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vienna Institute for Research in Ocular Surgery

Vienna, 1140, Austria

Location

Hanusch-Krankenhaus

Vienna, A-1140, Austria

Location

Related Publications (5)

  • 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.

    PMID: 25500982BACKGROUND

  • 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.

    PMID: 12364725BACKGROUND

  • 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.

    PMID: 19577305BACKGROUND

  • 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.

    PMID: 24503410BACKGROUND

  • 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.

    PMID: 22809785BACKGROUND

MeSH Terms

Conditions

Retinal Artery Occlusion

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 7, 2016

First Posted

February 10, 2016

Study Start

December 1, 2014

Primary Completion

July 31, 2017

Study Completion

July 31, 2018

Last Updated

October 22, 2019

Record last verified: 2019-10

Locations

AU(2)