Vascular Fundus Changes in Patients With High Probability of Chronic Cerebrospinal Venous Insufficiency (CCSVI)

NCT01356134 | Completed DMC

• 1 other identifier: 61/3527
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ehlers-Danlos Syndrome; Multiple Sclerosis

Keywords

multiple sclerosis; ehlers danlos syndrome; CCSVI; chronic cerebrospinal venous insufficiency; fundus; retina

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Multiple sclerosis and or Ehlers-Danlos

Patients with suspected or confirmed cases of Ehlers Danlos Syndrome and or Multiple Sclerosis

Age matched normals

Age matched normals

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• age matched normals
• patients with diagnosed or suspected Ehlers-Danlos Syndrome and/or diagnosed or suspected Multiple Sclerosis ("CIS")

You may not qualify if:

• diabetics and patients unable to sit in position for testing are excluded

Sponsors & Collaborators

• Genetic Disease Investigators: lead
• Optos, PLC: collaborator

Study Sites (1)

Total Eye Care

Colleyville, Texas, 76034, United States

Location

Related Publications (3)

• 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.

  PMID: 18208891 BACKGROUND

• 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.

  PMID: 19724286 BACKGROUND

• 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.

  PMID: 19060024 BACKGROUND

MeSH Terms

Conditions

Ehlers-Danlos Syndrome; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Diana L Driscoll, O.D.

  Genetic Disease Investigators

  STUDY DIRECTOR

• Richard A Driscoll, O.D.

  Genetic Disease Investigators

  PRINCIPAL INVESTIGATOR

• Clair A Francomano, M.D.

  Harvey Institute for Human Genetics

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 12, 2011
• First Posted: May 19, 2011
• Study Start: May 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 3, 2015

Record last verified: 2015-04

Locations

US (1)