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

Post-Traumatic Stress Disorder Clinical Trial

— VDMTBI  

Official title:

Visual Dysfunction in MTBI: A Comparison Group Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00671450
• Other study ID #: SHP 08-142
• Status: Completed
• Phase: N/A
• First received: April 30, 2008
• Last updated: January 24, 2013
• Start date: October 2008
• Est. completion date: August 2009

Study information

• Verified date: August 2009
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 39 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Concussion
• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Vision Disorders

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of binocular dysfunction		The primary outcome will be measured at a single visual screen lasting approximately one hour.	No