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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00013377
Other study ID # C1982R
Secondary ID
Status Completed
Phase Phase 2
First received March 14, 2001
Last updated January 20, 2009
Start date April 1999
Est. completion date March 2002

Study information

Verified date January 2001
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

There are two diseases in particular that may have serious consequences for driving and mobility due to their potentially severe impact on visual function: glaucoma and diabetic neuropathy. In this project we will develop predictive models of driving for these patients and will train them to use low-vision aids to improve driving mobility. We will determine how best to train patients with hemianopic field loss due to cerebral vascular accidents and identify predictors of long-term success in the use of low-vision aids.


Description:

There are two diseases in particular that may have serious consequences for driving and mobility due to their potentially severe impact on visual function: glaucoma and diabetic neuropathy. Both these diseases can potentially result in significant peripheral visual field loss, sometimes coupled with decreased visual acuity. We have previously demonstrated that each of these visual losses alone can have significant impact on driving and mobility performance. In this project we will develop predictive models of driving for these patients and apply our extensive expertise in training patients to use low-vision aids to improve driving mobility. A second question that will be addressed is how to best train scanning patients with hemianopic field loss due to cerebral vascular accidents. We propose to configure the prisms in a bioptic form similar to previously used for amorphic lenses in RP and for bioptic telescopes for patients in macular disease. The third problem that will be addressed is the identification of predictors of long-term success in the use of low-vision aids.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Eye impairment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Procedure:
Low vision


Locations

Country Name City State
United States VAMC (West Side) Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

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