Low Vision Intervention Trial II (LOVIT II)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Central Vision Loss From Macular Diseases |
Other: Interdisciplinary Low Vision Service Other: Basic Low Vision Service |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | VA Low Vision Intervention Trial (LOVIT) II |
- Comparison of changes in visual reading ability from baseline to three months later measured with 48 item VA Low Vision Visual Functioning Questionnaire [ Time Frame: changes from baseline to 4 months later ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 330 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.
|
Other: 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.
Other Name: Interdisciplinary Low Vision Rehabilitation
|
|
Active Comparator: Arm 2
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
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.
Other Name: Basic Low Vision Rehabilitation
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Nancy Ellis, MS | (414) 384-2000 ext 41514 | nancy.ellis2@va.gov |
| United States, Illinois | |
| Edward Hines, Jr. VA Hospital | Recruiting |
| Hines, Illinois, United States, 60141-5000 | |
| Contact: Susan Andrese 708-202-8387 ext 27447 Susan.Andrese@va.gov | |
| Principal Investigator: Joan Stelmack, OD MPH | |
| Sub-Investigator: Kevin T. Stroupe, BS MA PhD | |
| United States, Maryland | |
| VA Maryland Health Care System, Baltimore | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Rex Ballinger, OD 410-605-7230 rex.ballinger@va.gov | |
| United States, North Carolina | |
| Salisbury VAMC | Withdrawn |
| Salisbury, North Carolina, United States, 28144 | |
| United States, Ohio | |
| VA Medical Center, Cincinnati | Recruiting |
| Cincinnati, Ohio, United States, 45220 | |
| Contact: Timothy Morand, OD 513-861-3100 ext 5372 Timothy.Morand@va.gov | |
| VA Medical Center, Dayton | Recruiting |
| Dayton, Ohio, United States, 45428 | |
| Contact: Timothy Morand, OD 937-268-6511 ext 3303 Timothy.Morand2@va.gov | |
| United States, Pennsylvania | |
| VA Medical Center, Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Denise Wilcox, OD 215-823-4110 denise.wilcox@va.gov | |
| United States, Wisconsin | |
| William S. Middleton Memorial Veterans Hospital, Madison | Recruiting |
| Madison, Wisconsin, United States, 53705 | |
| Contact: Karen Brahm, OD 608-256-1901 ext 17034 karen.brahm2@va.gov | |
| Zablocki VA Medical Center, Milwaukee | Recruiting |
| Milwaukee, Wisconsin, United States, 53295-1000 | |
| Contact: Kenneth M Rose, OD 414-384-2000 ext 45902 kenneth.rose@va.gov | |
| Principal Investigator: | Joan Stelmack, OD MPH | Edward Hines Jr. VA Hospital |
More Information
Publications:
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00958360 History of Changes |
| Other Study ID Numbers: | C6958-R |
| Study First Received: | August 11, 2009 |
| Last Updated: | May 2, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
vision, low |
Additional relevant MeSH terms:
|
Vision, Low Blindness Vision Disorders Sensation Disorders |
Neurologic Manifestations Nervous System Diseases Eye Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013