Low Vision Intervention Trial II (LOVIT II)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00958360
First received: August 11, 2009
Last updated: August 15, 2014
Last verified: August 2014
  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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 ]

Enrollment: 323
Study Start Date: August 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: January 2015 (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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00958360

Locations
United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-5000
United States, Maryland
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States, 21201
United States, Ohio
VA Medical Center, Cincinnati
Cincinnati, Ohio, United States, 45220
VA Medical Center, Dayton
Dayton, Ohio, United States, 45428
United States, Pennsylvania
VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Wisconsin
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Madison, Wisconsin, United States, 53705
Zablocki VA Medical Center, Milwaukee
Milwaukee, Wisconsin, United States, 53295-1000
Sponsors and Collaborators
Investigators
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: August 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
vision, low

ClinicalTrials.gov processed this record on September 30, 2014