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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Total Eye Care

Colleyville, Texas, 76034, United States

About this study

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®.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Genetic Disease Investigators

Other

Collaborators

Optos, PLC

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: May 19, 2011
Registry last updated: Apr 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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