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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00671450
Other study ID # SHP 08-142
Secondary ID
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


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
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