This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Optos, PLC.
Information provided by (Responsible Party):
Diana Driscoll, O.D., Genetic Disease Investigators Identifier:
First received: May 12, 2011
Last updated: April 2, 2015
Last verified: April 2015
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.

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 Diana Driscoll, O.D., Genetic Disease Investigators:

Primary Outcome Measures:
  • 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.

Enrollment: 60
Study Start Date: May 2011
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
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®.

Ages Eligible for Study:   Child, Adult, Senior
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
  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 identifier: NCT01356134

United States, Texas
Total Eye Care
Colleyville, Texas, United States, 76034
Sponsors and Collaborators
Genetic Disease Investigators
Optos, PLC.
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:
Responsible Party: Diana Driscoll, O.D., Principal Investigator, Genetic Disease Investigators Identifier: NCT01356134     History of Changes
Other Study ID Numbers: 61/3527
Study First Received: May 12, 2011
Last Updated: April 2, 2015

Keywords provided by Diana Driscoll, O.D., Genetic Disease Investigators:
multiple sclerosis
ehlers danlos syndrome
chronic cerebrospinal venous insufficiency

Additional relevant MeSH terms:
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 processed this record on September 21, 2017