- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00671450
Visual Dysfunction in Mild Traumatic Brain Injury (MTBI): A Comparison Group Study (VDMTBI)
January 24, 2013 updated by: US Department of Veterans Affairs
Visual Dysfunction in MTBI: A Comparison Group Study
In an on-going study of visual characteristics of personnel diagnosed with a mild traumatic brain injury (MTBI) related to their service in Iraq and Afghanistan we found a high rate of binocular vision problems (such as double/blurry vision, reading difficult, etc.).
These individuals are also usually diagnosed with post traumatic stress disorder (PTSD).
PTSD is known to cause some vision symptoms.
We wish to conduct this study on individuals with PTSD (but not an MTBI) to see if they have symptoms similar to those in individuals who have MTBI.
This will provide us with information useful in determining the specific cause of the visual symptoms in the MTBI population.
Study Overview
Status
Completed
Conditions
Detailed Description
We will recruit 75 patients diagnosed with PTSD, but with no history of mild traumatic brain injury (MTBI), from the population of the VAPAHCS PTSD Center and Clinics.
These volunteers will be scheduled for an eye screening developed for a concurrent project to assess visual dysfunction (accommodation/vergence insufficiency, pursuit/saccade deficits, etc.) in patients diagnosed with MTBI and seen at the Palo Alto Polytrauma Network Site clinic.
The MTBI patients have unexpectedly high rates of binocular dysfunction, although their visual acuities and visual fields are normal/near normal.
The MTBI diagnosis is associated with a combat blast event in some 90% of cases.
Th majority of this population has also been diagnosed with PTSD.
PTSD is known to cause some visual symptoms, thus it is necessary for us to determine if the visual dysfunctions in the MTBI are related to their PTSD diagnosis or not.
The volunteer participants will be scheduled for an eye screening and consented prior to the screening.
Inclusion criteria include diagnosis of PTSD, aged 19 to 39, and willingness to participate.
Exclusion criteria is primarily history of TBI.
The visual screen includes assessments of visual acuity, visual field, self-reported visual function (i.e., light sensitivity, eye fatigue, reading difficulty), and measures of accommodative function, vergence, pursuit and saccades.
The data collected will be compared to the data from the ongoing study of visual dysfunction in patients diagnosed with MTBI.
Study Type
Observational
Enrollment (Anticipated)
75
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Palo Alto, California, United States, 94304-1290
- VA Palo Alto Health Care System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 39 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants will be drawn from the patient population of the VAPAHCS PTSD Center and Clinics.
Description
Inclusion Criteria:
- diagnosis of PTSD
- no history of MTBI
- between 19 and 39 years of age
- a veteran
Exclusion Criteria:
- a history of MTBI
- over the age of 39
- an unwillingness to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group 1
Participants will be patients diagnosed with PTSD but with no history of TBI.
Participants must be between the ages of 19 and 39.
Participants must be compentent to sign a consent form and be willing ot participate in a vision screening.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Presence or absence of binocular dysfunction
Time Frame: The primary outcome will be measured at a single visual screen lasting approximately one hour.
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The primary outcome will be measured at a single visual screen lasting approximately one hour.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gregory L Goodrich, PhD, VA Palo Alto Health Care System
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (ACTUAL)
July 1, 2009
Study Completion (ACTUAL)
August 1, 2009
Study Registration Dates
First Submitted
April 30, 2008
First Submitted That Met QC Criteria
May 4, 2008
First Posted (ESTIMATE)
May 5, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
January 28, 2013
Last Update Submitted That Met QC Criteria
January 24, 2013
Last Verified
August 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHP 08-142
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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