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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
Sponsor:
Collaborator:
Optos, PLC
Information provided by (Responsible Party):
Diana Driscoll, O.D., Genetic Disease Investigators

Tracking Information
First Submitted Date May 12, 2011
First Posted Date May 19, 2011
Last Update Posted Date April 3, 2015
Study Start Date May 2011
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 17, 2011)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01356134 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Vascular Fundus Changes in Patients With High Probability of Chronic Cerebrospinal Venous Insufficiency (CCSVI)
Official Title Vascular Fundus Changes in Patients With High Probability of CCSVI (Chronic Cerebrospinal Venous Insufficiency)
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.
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®.
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Ehlers-Danlos Syndrome
  • Multiple Sclerosis
Intervention Not Provided
Study 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 17, 2011)
60
Original Estimated Enrollment Same as current
Actual Study Completion Date April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01356134
Other Study ID Numbers 61/3527
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Diana Driscoll, O.D., Genetic Disease Investigators
Study Sponsor Genetic Disease Investigators
Collaborators 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
PRS Account Genetic Disease Investigators
Verification Date April 2015