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

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ClinicalTrials.gov Identifier: NCT01356134
Recruitment Status : Completed
First Posted : May 19, 2011
Last Update Posted : April 3, 2015
Optos, PLC
Information provided by (Responsible Party):
Diana Driscoll, O.D., Genetic Disease Investigators

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.

Condition or disease
Ehlers-Danlos Syndrome Multiple Sclerosis

Detailed Description:
Chronic Cerebrospinal Venous Insufficiency (CCSVI) has been proposed as the cause of numerous neurodegenerative diseases of the brain. CCSVI is the result of poor drainage of blood (and cerebral spinal fluid to some degree) from weakened or stenosed veins usually located in the cervical area (most notably the internal jugular veins). Although current focus and treatment of CCSVI is on multiple sclerosis, CCSVI has also been implicated as a potential cause of Alzheimer's disease and Parkinson's Disease. Additionally, patients with Ehlers-Danlos Syndrome (EDS) -- a disorder of connective tissue -- are more prone to developing multiple sclerosis than the general population. Many EDS patients are known to have weakened and abnormal blood vessels and 40 - 70% of EDS patients develop autonomic dysfunction in addition to numerous other symptoms found in patients with CCSVI. In the small subset of EDS and multiple sclerosis patients seen at Total Eye Care, the investigators have noticed a vascular irregularity (using the optomap® and examining the results under high magnification) which offers credence to the theory of CCSVI. Such objective data has been elusive, excepting for fMRI, ultrasound (to a limited degree) and venous angioplasty results. Current treatment of CCSVI involves the ballooning and sometimes stenting, of abnormally stenosed veins. The treatment of CCSVI offers hope to many patients suffering from multiple sclerosis. Although CCSVI research is in its infancy, many doctors believe that CCSVI is a significant portion of the solution to patients with neurodegenerative diseases of the brain. Because CCSVI is a vascular disorder, the investigators hypothesize that the investigators are able to screen candidates for CCSVI via the optomap®.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Vascular Fundus Changes in Patients With High Probability of CCSVI (Chronic Cerebrospinal Venous Insufficiency)
Study Start Date : May 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

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

Primary Outcome Measures :
  1. Fundus: venous engorgement/beading [ Time Frame: Baseline ]
    Abnormal vessel appearance in fundi may include venous engorgement and beading, abnormal A/V ratio, blurred disc margins, papilledema, dot hemorrhages or exudates.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01356134

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United States, Texas
Total Eye Care
Colleyville, Texas, United States, 76034
Sponsors and Collaborators
Genetic Disease Investigators
Optos, PLC
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Study Director: Diana L Driscoll, O.D. Genetic Disease Investigators
Principal Investigator: Richard A Driscoll, O.D. Genetic Disease Investigators
Study Chair: Clair A Francomano, M.D. Harvey Institute for Human Genetics
Additional Information:
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Responsible Party: Diana Driscoll, O.D., Principal Investigator, Genetic Disease Investigators
ClinicalTrials.gov Identifier: NCT01356134    
Other Study ID Numbers: 61/3527
First Posted: May 19, 2011    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015
Keywords provided by Diana Driscoll, O.D., Genetic Disease Investigators:
multiple sclerosis
ehlers danlos syndrome
chronic cerebrospinal venous insufficiency
Additional relevant MeSH terms:
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Multiple Sclerosis
Venous Insufficiency
Ehlers-Danlos Syndrome
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases
Hemostatic Disorders
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Skin Diseases