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Vascular Fundus Changes in Patients With High Probability of Chronic Cerebrospinal Venous Insufficiency (CCSVI)
This study is currently recruiting participants.
Verified May 2011 by Genetic Disease Investigators

First Received on May 12, 2011.   Last Updated on May 17, 2011   History of Changes
Sponsor: Genetic Disease Investigators
Collaborator: Optos plc
Information provided by: Genetic Disease Investigators
ClinicalTrials.gov Identifier: NCT01356134
  Purpose

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
Ehlers-Danlos Syndrome
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Vascular Fundus Changes in Patients With High Probability of CCSVI (Chronic Cerebrospinal Venous Insufficiency)

Resource links provided by NLM:


Further study details as provided by Genetic Disease Investigators:

Primary Outcome Measures:
  • Fundus: venous engorgement/beading [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Abnormal vessel appearance in fundi may include venous engorgement and beading, abnormal A/V ratio, blurred disc margins, papilledema, dot hemorrhages or exudates.


Estimated Enrollment: 60
Study Start Date: May 2011
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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®.

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01356134

Contacts
Contact: Diana L Driscoll, O.D. 817.416.0333 DrDiana@Prettyill.com
Contact: Rich A Driscoll, O.D. 817.431.4900 RDriscoll@TotalEyeCare.net

Locations
United States, Texas
Total Eye Care Recruiting
Colleyville, Texas, United States, 76034
Contact: Richard A Driscoll, O.D.     817-416-0333     RDriscoll@TotalEyeCare.net    
Contact: Diana L Driscoll, O.D.     817.416.0333     DrDiana@Prettyill.com    
Principal Investigator: Richard A Driscoll, O.D.            
Sponsors and Collaborators
Genetic Disease Investigators
Optos plc
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: Genetic Disease Investigators
ClinicalTrials.gov Identifier: NCT01356134     History of Changes
Other Study ID Numbers: 61/3527
Study First Received: May 12, 2011
Last Updated: May 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Genetic Disease Investigators:
multiple sclerosis
ehlers danlos syndrome
CCSVI
chronic cerebrospinal venous insufficiency
fundus
retina

Additional relevant MeSH terms:
Ehlers-Danlos Syndrome
Multiple Sclerosis
Sclerosis
Venous Insufficiency
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
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
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2012