Low Vision Intervention Trial II (LOVIT II)

Study Overview
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Brief Summary
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This study will determine if the interdisciplinary team low vision rehabilitation program is more effective than basic low vision care provided by an optometrist working alone in improving visual reading ability in veterans with macular diseases and best corrected visual acuity of 20/50 to 20/200.

Detailed Description
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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.

Official Title
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VA Low Vision Intervention Trial (LOVIT) II

Conditions
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Central Vision Loss From Macular Diseases

Intervention / Treatment
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* Other: Interdisciplinary Low Vision Service
* Other: Basic Low Vision Service


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework. | Other: Interdisciplinary Low Vision Service<br>* Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed.<br>* Other names: Interdisciplinary Low Vision Rehabilitation;|
| Active Comparator: Arm 2<br>Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework. | Other: Basic Low Vision Service<br>* Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time.<br>* Other names: Basic Low Vision Rehabilitation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Changes in Visual Reading Ability From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire | The range of scores for the Visual Reading Ability subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities. | changes from baseline to 4 months later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Changes in Mobility From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire | The range of scores for the Mobility subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities. | changes from baseline to 4 months later | 
| Comparison of Changes in Visual Information Processing From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire | The range of scores for the Visual Information Processing subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities. | changes from baseline to 4 months later | 
| Comparison of Changes in Visual Motor Skills From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire | The range of scores for the Visual Motor Skills subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities. | changes from baseline to 4 months later | 
| Comparison of Overall Visual Ability From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire | The range of scores for the Overall Visual Ability subscale of the VA Low Vision Visual Functioning Questionnaire is 0 to 3.5 logits (log odds ratio). A higher score indicates better ability or less difficulty performing activities. | changes from baseline to 4 months later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vision, low