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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Genetic Disease Investigators.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Optos, PLC.
Information provided by (Responsible Party):
Diana Driscoll, O.D., Genetic Disease Investigators
ClinicalTrials.gov Identifier:
NCT01356134
First received: May 12, 2011
Last updated: July 14, 2012
Last verified: July 2012
  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 2012
Primary Completion Date: July 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
Total Eye Care
Colleyville, Texas, United States, 76034
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: Diana Driscoll, O.D., Principal Investigator, Genetic Disease Investigators
ClinicalTrials.gov Identifier: NCT01356134     History of Changes
Other Study ID Numbers: 61/3527
Study First Received: May 12, 2011
Last Updated: July 14, 2012
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
Syndrome
Venous Insufficiency
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Cardiovascular Diseases
Collagen Diseases
Congenital Abnormalities
Connective Tissue Diseases
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Disease
Genetic Diseases, Inborn
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Skin Abnormalities
Skin Diseases
Skin Diseases, Genetic
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014