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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework. |
|
| Arm 2 | Active Comparator | Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interdisciplinary Low Vision Service | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joan Stelmack, OD MPH | Edward Hines Jr. VA Hospital, Hines, IL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edward Hines Jr. VA Hospital, Hines, IL | Hines | Illinois | 60141-5000 | United States | ||
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22958237 | Background | Stelmack JA, Tang XC, Reda DJ, Stroupe KT, Rinne S, Massof RW; LOVIT II Study Group. VA LOVIT II: a protocol to compare low vision rehabilitation and basic low vision. Ophthalmic Physiol Opt. 2012 Nov;32(6):461-71. doi: 10.1111/j.1475-1313.2012.00933.x. Epub 2012 Sep 7. | |
| 31592954 | Derived | Stelmack JA, Tang C, Wei Y, Rose K, Ballinger R, Whitman O, Chronister C, Sayers S, Massof RW; LOVIT II Study Group. Veterans Affairs Low-vision Intervention Trial II: One-year Follow-up. Optom Vis Sci. 2019 Oct;96(10):718-725. doi: 10.1097/OPX.0000000000001428. |
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A total of 2,051 patients were screened, of whom 1,728 were excluded (1,706 ineligible per chart review and 22 ineligible after screening).
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| ID | Title | Description |
|---|---|---|
| FG000 | Interdisciplinary Low Vision Rehabilitation Group | Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework. Interdisciplinary Low Vision Service: 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. |
| FG001 | Basic Low Vision Care Group | Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework. Basic Low Vision Service: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Interdisciplinary Low Vision Rehabilitation Group | Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework. Interdisciplinary Low Vision Service: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | logits | changes from baseline to 4 months later |
|
Adverse event data was collected from inception of the study to 4-month follow-up.
This is a low risk non-interventional study. Adverse events were pre-specified in the case report forms and assessed at the 4-month follow-up interview by self-reporting by participants or notification by a family member.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interdisciplinary Low Vision Rehabilitation Group | Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework. Interdisciplinary Low Vision Service: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-study related Death | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| eye hemorrhage | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joan Stelmack, O.D., M.P.H. | Hines VA Blind Center | 708-202-2124 | joan.stelmack@va.gov |
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| ID | Term |
|---|---|
| D015354 | Vision, Low |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
|
| Basic Low Vision Service | Other | 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. |
|
|
| 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 |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Cincinnati VA Medical Center, Cincinnati, OH | Cincinnati | Ohio | 45220 | United States |
| Dayton VA Medical Center, Dayton, OH | Dayton | Ohio | 45428 | United States |
| Philadelphia VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania | 19104 | United States |
| William S. Middleton Memorial Veterans Hospital, Madison, WI | Madison | Wisconsin | 53705 | United States |
| Clement J. Zablocki VA Medical Center, Milwaukee, WI | Milwaukee | Wisconsin | 53295-1000 | United States |
| 29800250 | Derived | Stroupe KT, Stelmack JA, Tang XC, Wei Y, Sayers S, Reda DJ, Kwon E, Massof RW; LOVIT II Study Group. Economic Evaluation of Low-Vision Rehabilitation for Veterans With Macular Diseases in the US Department of Veterans Affairs. JAMA Ophthalmol. 2018 May 1;136(5):524-531. doi: 10.1001/jamaophthalmol.2018.0797. |
| 27978569 | Derived | Stelmack JA, Tang XC, Wei Y, Wilcox DT, Morand T, Brahm K, Sayers S, Massof RW; LOVIT II Study Group. Outcomes of the Veterans Affairs Low Vision Intervention Trial II (LOVIT II): A Randomized Clinical Trial. JAMA Ophthalmol. 2017 Feb 1;135(2):96-104. doi: 10.1001/jamaophthalmol.2016.4742. |
| Physician Decision |
|
| Lost to Follow-up |
|
| BG001 | Basic Low Vision Care Group | Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework. Basic Low Vision Service: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Basic Low Vision Care Group | Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework. Basic Low Vision Service: 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. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | logits | changes from baseline to 4 months later |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | logits | changes from baseline to 4 months later |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | logits | changes from baseline to 4 months later |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | logits | changes from baseline to 4 months later |
|
|
|
|
| 27 |
| 163 |
| 10 |
| 163 |
| EG001 | Basic Low Vision Care Group | Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework. Basic Low Vision Service: 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. | 29 | 160 | 1 | 160 |
| Non-study related Prolonged Hospitalization | Cardiac disorders | Non-systematic Assessment |
|
| Non-study related Prolonged Hospitalization | Endocrine disorders | Non-systematic Assessment |
|
| Non-study related Prolonged Hospitalization | Eye disorders | Non-systematic Assessment |
|
| Non-study related Prolonged Hospitalization | Gastrointestinal disorders | Non-systematic Assessment |
|
| Non-study related Prolonged Hospitalization | General disorders | Non-systematic Assessment |
|
| Non-study related Prolonged Hospitalization | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Non-study related Prolonged Hospitalization | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Non-study related Prolonged Hospitalization | Renal and urinary disorders | Non-systematic Assessment |
|
| Non-study related Prolonged Hospitalization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Non-study related Prolonged Hospitalization | Vascular disorders | Non-systematic Assessment |
|
| CME | Eye disorders | Non-systematic Assessment |
|
| other health reason | General disorders | Non-systematic Assessment |
|
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| D005128 |
| Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |