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VA Low Vision Intervention Trial (LOVIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00223756
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 8, 2016
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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 or disease Intervention/treatment Phase
Vision, Low Other: Low Vision Intervention - Outpatient Training Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: VA Low Vision Intervention Trial
Study Start Date : November 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : August 2007

Arm Intervention/treatment
Experimental: Arm 1
interdisciplinary, outpatient blind rehabilitation
Other: Low Vision Intervention - Outpatient Training Program
Patients receive LV therapy as outpatients
Other Name: Therapy Group

No Intervention: Arm 2
usual care

Primary Outcome Measures :
  1. VA LV VFQ-48 Reading Domain Scores [ Time Frame: 4 months from baseline ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00223756

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United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-5000
Sponsors and Collaborators
VA Office of Research and Development
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Principal Investigator: Joan Stelmack, OD MPH Edward Hines Jr. VA Hospital
Publications of Results:
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Responsible Party: VA Office of Research and Development Identifier: NCT00223756    
Other Study ID Numbers: C3457-R
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016
Keywords provided by VA Office of Research and Development:
Vision, Low
Additional relevant MeSH terms:
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Vision, Low
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases