NCT01356134|CompletedDMC
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Sponsor study identifier
observational
60
1 country
1
Study Start
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2015
Actual (reported)Study Completion
April 2015
Actual (reported)The investigators propose that evidence of chronic cerebrospinal venous insufficiency (CCSVI) may be evident in the vasculature of the fundus. The investigators will be examining fundi of multiple sclerosis patients and Ehlers-Danlos patients to see if evidence of CCSVI can be found in these patients having high risk for CCSVI. The investigators will read the fundus photos, compared to age-matched normals in a "blind" fashion.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
May 12, 2011
Actual (reported)May 19, 2011
Actual (reported)April 2015
Actual (reported)April 2015
Actual (reported)Fundus: venous engorgement/beading
Abnormal vessel appearance in fundi may include venous engorgement and beading, abnormal A/V ratio, blurred disc margins, papilledema, dot hemorrhages or exudates.
Baseline
Patients with suspected or confirmed cases of Ehlers Danlos Syndrome and or Multiple Sclerosis
Age matched normals
Aged-matched normals are patients at Total Eye Care. Multiple sclerosis and/or Ehlers-Danlos patients will be accepted from any area, and will not be excluded based on location of residence. They need not be patients of Total Eye Care.
Total Eye Care
Colleyville, Texas, 76034, United States
Vilisaar J, Harikrishnan S, Suri M, Constantinescu CS. Ehlers-Danlos syndrome and multiple sclerosis: a possible association. Mult Scler. 2008 May;14(4):567-70. doi: 10.1177/1352458507083187. Epub 2008 Jan 21.
Singh AV, Zamboni P. Anomalous venous blood flow and iron deposition in multiple sclerosis. J Cereb Blood Flow Metab. 2009 Dec;29(12):1867-78. doi: 10.1038/jcbfm.2009.180. Epub 2009 Sep 2.
Diana L Driscoll, O.D.
Genetic Disease Investigators
Richard A Driscoll, O.D.
Genetic Disease Investigators
Clair A Francomano, M.D.
Harvey Institute for Human Genetics
60 participants (actual enrollment reported by the registry).
First Submitted
May 12, 2011
First Posted
May 19, 2011
Study Start
May 2011
Date type not reportedThis date has not been verified as actual or estimated.
Endovascular Treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI)
Contact the study team to confirm eligibility.
Zamboni P, Galeotti R, Menegatti E, Malagoni AM, Tacconi G, Dall'Ara S, Bartolomei I, Salvi F. Chronic cerebrospinal venous insufficiency in patients with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2009 Apr;80(4):392-9. doi: 10.1136/jnnp.2008.157164. Epub 2008 Dec 5.
Primary Completion
April 2015
Actual (reported)Study Completion
April 2015
Actual (reported)Last Updated
April 3, 2015
Record last verified: 2015-04
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Source: ClinicalTrials.gov.
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