Low Vision Intervention Trial II (LOVIT II)

Key Questions: The purpose of our proposed single-masked multicenter randomized controlled
trial is to determine if the Interdisciplinary Team approach to low vision service delivery
is more effective than the Basic Low Vision Service in improving visual reading ability for
330 veterans with macular diseases and best corrected visual acuity of 20/50-20/200.
Effectiveness will be measured with the Veterans Affairs Low Vision Visual Functioning
Questionnaire (VA LV VFQ-48), a valid and reliable questionnaire that is administered by
telephone to capture changes in patients' self-report of their difficulty reading and
performing other daily living activities affected by visual impairment before and after
rehabilitation. The primary outcome measure is the comparison of changes in patients' visual
reading ability on the VA LV VFQ-48 after they receive low vision care from the
Interdisciplinary Team or Basic Low Vision Care program. The secondary outcome measures are
comparisons of changes in other VA LV VFQ-48 visual ability scores (overall, mobility,
visual information processing, visual motor skills). Hypothesis: The improvement in visual
reading ability measured with the VA LV VFQ-48 will be larger for patients who received low
vision services from the Interdisciplinary Team than for patients who received the Basic Low
Vision Service. Specific Aims:(1) Compare the mean changes in patients' visual reading
ability (estimated from patients' difficulty ratings of reading items on the VA LV VFQ-48
before and after low vision service delivery) in the Interdisciplinary Team and Basic Low
Vision Care Programs.(2) Compare the mean changes in visual ability [patients' difficulty
ratings of other items on the VA LV VFQ-48 (mobility, visual information processing, visual
motor skills) before and after low vision service delivery] in the Interdisciplinary Team
and Basic Low Vision Care programs.(3). Identify the characteristics of patients who benefit
from the Interdisciplinary Team and Basic Low Vision Service. (4). Conduct an economic
evaluation to compare the costs and cost effectiveness of the Interdisciplinary Team and
Basic Low Vision Service.

Inclusion Criteria:

- Primary eye diagnosis (better seeing Eye) macular disease

- Best-corrected visual acuity (better seeing eye) 20/50-20/200

Exclusion Criteria:

- Does not have a telephone

- Does not speak English

- Has received interdisciplinary low vision services

- English literacy less that 5th grade reading level

- Failed TICS

- Unable or unwilling to attend required clinic visits

- Severe hearing impairment preventing administration of telephone questionnaires

- Planned cataract extraction in next 4 months

- Visual fields contracted to diameter of 20 degrees in better-seeing eye

- Vitreous hemorrhage or serous hemorrhagic detachment of macula

- CNVM treated with fewer than 3 anti-VEGF injections

- Diabetic macular edema (DME) treated with focal/grid laser within the last two months

- DME treated with intravitreal injections of anti-VEGF or intravitreal triamcinolone
acetonide (IVTA) within the last two months

- Cystoid macular edema (CME) treated with topical (non-steroidal anti-inflammatory
drugs) NSAIDS, topical steroids or IVTA within the last three months