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OpenTrials
Completed

NCT Number: NCT00671450

Visual Dysfunction in Mild Traumatic Brain Injury (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.

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Key information

Age range

19 year–39 year

Sex eligibility

All sexes

Study type

Observational

Primary location

VA Palo Alto Health Care System

Palo Alto, California, 94304-1290, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Presence or absence of binocular dysfunction

    Time frame: The primary outcome will be measured at a single visual screen lasting approximately one hour.

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Official study title

Visual Dysfunction in MTBI: A Comparison Group Study

Acronym: VDMTBI

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 5, 2008
Registry last updated
Jan 28, 2013

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.

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