VA Low Vision Intervention Trial

Abstract: Research Question:

Estimates are that there will be 854,000 severely visually impaired veterans in the year
2005 and 890,000 in the year 2010. Statistics, based upon the 2000 census, suggest that it
will be well into the next decade before the number of severely visually impaired veterans
begins to decrease. Waiting time for admission to VA blind rehabilitation centers (BRCs) is
often a year or more. Low vision services are an important aspect of blind rehabilitation,
as 85% of veterans admitted to BRCs have useful remaining vision. In the private sector, low
vision services are provided in outpatient settings. Yet, legally blind veterans are still
encouraged, if not required, to attend regional inpatient programs to obtain therapy with
low vision devices because a reimbursement model is not available for outpatient blind
rehabilitation and few low vision outpatient clinics have rehabilitation professionals to
provide this training. The VA system needs alternative service delivery options for veterans
who are unable to participate in inpatient rehabilitation. Outpatient low vision programs
should provide continuity of care with the regional BRC programs and insure local access to
low vision care that is high quality, timely, and cost-effective. Currently, the VERA
Reimbursement Model allocates $27,826 per blind rehabilitation admission. Outpatient low
vision programs have the potential to substitute for inpatient low vision services and more
costly inpatient rehabilitation programs may not be necessary for higher functioning
veterans. The purpose of the proposed research is to measure the effectiveness of a low
vision outpatient program for legally blind veterans with central vision loss from macular
diseases that could be provided at local VA facilities.

Specific Objectives are to:

1. Compare the mean change in self-report of difficulty performing daily activities
measured with the Veteran's Affairs Low Vision Visual Function Questionnaire - 48 (VA
LV VFQ-48) reading domain scores from baseline to 4 months after randomization [two
months after veterans participate in a low vision outpatient program or usual care
(waiting list) control group].

2. Determine if the mean change in VA LV VFQ-48 composite and reading domain scores from
baseline to 4 months after randomization [two months after veterans participate in a
low vision outpatient program or usual care (waiting list) control group] can be
predicted by baseline measures of visual impairment, functional status and life state
or explained by measures of functional status after rehabilitation.

3. Perform an economic evaluation of costs and cost-effectiveness of the low vision
outpatient program.

4. Compare the mean change in VA LV VFQ-48 scores from the clinical trial from baseline to
4 months after randomization (two months after veterans participate in a low vision
outpatient program) to historical data on the mean change in VA LV VFQ-48 scores from
the Hines BRC program.

Hypothesis: Compared to the usual care (waiting list) control group, veterans in the
treatment group will self-report a reduction of .78 logits or more in difficulty performing
daily living activities measured by the VA LV VFQ-48 reading domain scores from baseline to
4 months after randomization (two months after veterans participate in a low vision
outpatient program).The .78 logit change is clinically significant, as this improvement
corresponds to the change in visual ability that would accompany a 6-line improvement on an
EDTRS visual acuity chart.

Significance: The NIH includes visual impairment, chronic visual deficiencies that impair
everyday function that are not correctable by ordinary glasses, among the 10 most prevalent
causes of disability in America. Persons confronted with vision loss often feel limited and
frustrated performing everyday activities such as reading, traveling from place to place,
and recognizing objects or people. As a result, they may experience loss of self esteem,
social isolation, difficulty working and reduced independence. The low vision team evaluates
the level of remaining vision, prescribes special lenses or devices and techniques for using
remaining vision more effectively. Low vision rehabilitation restores independence by
enabling persons with vision loss to perform daily living tasks independently at home, at
work or within the community.

Research Design: the proposed study is a randomized clinical trial conducted at two sites.
Subjects are 122 legally blind veterans from Hines Hospital and Heffner VAMC. Veterans will
be randomized to treatment from a new low vision outpatient program or a usual care (waiting
list) control group. Following a low vision examination, veterans in the treatment group
will receive 5 (2-2 1/2 hour) therapy sessions at the local VA sites and one home visit to
evaluate the home environment and set up prescribed devices. The primary outcome measure is
change in reading domain scores on the VA LV VFQ-48, a telephone questionnaire where
subjects self-report their difficulty performing daily living activities in the community.
Other measures include, instructors rating of veteran's visual skills and use of low vision
devices after rehabilitation, visual skills for reading (PEPPER VSRT), health status
(SF-36), and symptoms of depression (CES-D). Outcomes will be compared with T tests.
Multiple linear regression models will be used to identify predictors and explain outcomes.
Costs and cost effectiveness of outpatient treatment compared to treatment in an inpatient
BRC will be evaluated.

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.