Visual Dysfunction in Mild Traumatic Brain Injury (MTBI): A Comparison Group Study (VDMTBI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00671450
Recruitment Status : Completed
First Posted : May 5, 2008
Last Update Posted : January 28, 2013
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Brief Summary:
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.

Condition or disease
Post-Traumatic Stress Disorder

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
Estimated Enrollment : 75 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Visual Dysfunction in MTBI: A Comparison Group Study
Study Start Date : October 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Presence or absence of binocular dysfunction [ Time Frame: The primary outcome will be measured at a single visual screen lasting approximately one hour. ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   19 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be drawn from the patient population of the VAPAHCS PTSD Center and Clinics.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00671450

United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1290
Sponsors and Collaborators
US Department of Veterans Affairs
Principal Investigator: Gregory L Goodrich, PhD VA Palo Alto Health Care System

Responsible Party: US Department of Veterans Affairs Identifier: NCT00671450     History of Changes
Other Study ID Numbers: SHP 08-142
First Posted: May 5, 2008    Key Record Dates
Last Update Posted: January 28, 2013
Last Verified: August 2009

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Vision Disorders
Trauma and Stressor Related Disorders
Mental Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms