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VA Low Vision Intervention Trial

This study has been completed.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00223756
  Purpose

The primary purpose of this research study is to evaluate the effectiveness of a new outpatient low vision rehabilitation program that is targeted to serve legally blind veterans with central vision loss. The hypothesis is that veterans in the treatment group will self-report less difficulty performing daily activities than veterans in the control group who are on a waiting list for VA low vision or blind rehabilitation programs.


Condition Intervention
Vision, Low
Procedure: Low Vision Intervention - Outpatient Training Program

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study
Official Title:   VA Low Vision Intervention Trial

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • VA LV VFQ-48 Reading Domain Scores [ Designated as safety issue: No ]

Estimated Enrollment:   61
Study Start Date:   November 2004
Study Completion Date:   August 2007
Primary Completion Date:   July 2006 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1 Procedure: Low Vision Intervention - Outpatient Training Program

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. Primary eye diagnosis (in better seeing eye) of either macular degeneration, macular dystrophy, macular hole or inflammatory disease of the macula
  2. Habitual visual acuity (in better seeing eye) better than 20/500 but less than 20/100

Exclusion Criteria:

  1. does not have a phone
  2. does not speak English
  3. has previously received low vision services as part of an inpatient blind rehabilitation program
  4. has participated in a low vision program that provided low vision devices to meet reading needs with low vision therapy administered by an occupational therapist or vision rehabilitation professional since most recent significant decrease in vision
  5. has English literacy less than 5th grade level
  6. has habitual visual acuity in better seeing eye of equal to or better than 20/100, less than or equal to 20/500
  7. fails Telephone Interview of Cognitive Status (TICS) screening (score of 30 or lower)
  8. has history of stroke with aphasia
  9. has other health condition that would preclude follow-up (e.g. significant malignancy or life-threatening disease)
  10. is unable or unwilling to attend clinic visits required for the study
  11. has severe hearing impairment that interferes with participation in telephone questionnaires
  12. reports significant loss of vision since last eye exam
  13. has vitreous hemorrhage, serous or hemorrhagic detachment of the macula, clinically significant macular edema or cystoid macular edema that is likely to result in further loss or improvement in vision after treatment in better seeing eye
  14. plans cataract extraction in the next 6 months.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223756

Locations
United States, Illinois
Edward Hines, Jr. VA Hospital    
      Hines, Illinois, United States, 60141-5000

Sponsors and Collaborators

Investigators
Principal Investigator:     Joan Stelmack, OD MPH     Edward Hines Jr. VA Hospital    
  More Information

Click here for more information about this study: VA Low Vision Intervention Trial  This link exits the ClinicalTrials.gov site
 

Publications indexed to this study:

Responsible Party:   Department of Veterans Affairs ( Stelmack, Joan - Principal Investigator )
Study ID Numbers:   C3457R
First Received:   September 13, 2005
Last Updated:   March 10, 2008
ClinicalTrials.gov Identifier:   NCT00223756
Health Authority:   United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Vision, Low  

Study placed in the following topic categories:
Signs and Symptoms
Sensation Disorders
Vision Disorders
Eye Diseases
Neurologic Manifestations
Vision, Low

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on September 04, 2008




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