Clinical trial NCT00958360: Low Vision Intervention Trial II (LOVIT II)
Official title: VA Low Vision Intervention Trial (LOVIT) II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Central Vision Loss From Macular Diseases
Keywords: vision, low
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-08-13
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of Changes in Visual Reading Ability From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire
timeFrame: changes from baseline to 4 months later
Secondary outcomes:
measure: Comparison of Changes in Mobility From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire
timeFrame: changes from baseline to 4 months later
measure: Comparison of Changes in Visual Information Processing From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire
timeFrame: changes from baseline to 4 months later
measure: Comparison of Changes in Visual Motor Skills From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire
timeFrame: changes from baseline to 4 months later
measure: Comparison of Overall Visual Ability From Baseline to Four Months Later Measured With 48 Item VA Low Vision Visual Functioning Questionnaire
timeFrame: changes from baseline to 4 months later
Other outcomes:
Locations:
city: Hines
country: United States
facility: Edward Hines Jr. VA Hospital, Hines, IL
state: Illinois
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
city: Cincinnati
country: United States
facility: Cincinnati VA Medical Center, Cincinnati, OH
state: Ohio
city: Dayton
country: United States
facility: Dayton VA Medical Center, Dayton, OH
state: Ohio
city: Philadelphia
country: United States
facility: Philadelphia VA Medical Center, Philadelphia, PA
state: Pennsylvania
city: Madison
country: United States
facility: William S. Middleton Memorial Veterans Hospital, Madison, WI
state: Wisconsin
city: Milwaukee
country: United States
facility: Clement J. Zablocki VA Medical Center, Milwaukee, WI
state: Wisconsin
Study officials:
affiliation: Edward Hines Jr. VA Hospital, Hines, IL
name: Joan Stelmack, OD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.