Low Vision Intervention Trial II (LOVIT II) (LOVIT II)

July 14, 2016 updated by: VA Office of Research and Development

VA Low Vision Intervention Trial (LOVIT) II

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

323

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Hines, Illinois, United States, 60141-5000
        • Edward Hines Jr. VA Hospital, Hines, IL
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Cincinnati VA Medical Center, Cincinnati, OH
      • Dayton, Ohio, United States, 45428
        • Dayton VA Medical Center, Dayton, OH
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Philadelphia VA Medical Center, Philadelphia, PA
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • William S. Middleton Memorial Veterans Hospital, Madison, WI
      • Milwaukee, Wisconsin, United States, 53295-1000
        • Clement J. Zablocki VA Medical Center, Milwaukee, WI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Basic Low Vision Rehabilitation

What is the study measuring?

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
Time Frame: changes from baseline to 4 months later
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
Time Frame: changes from baseline to 4 months later
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
Time Frame: changes from baseline to 4 months later
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
Time Frame: changes from baseline to 4 months later
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
Time Frame: changes from baseline to 4 months later
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Joan Stelmack, OD MPH, Edward Hines Jr. VA Hospital, Hines, IL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

August 11, 2009

First Submitted That Met QC Criteria

August 12, 2009

First Posted (ESTIMATE)

August 13, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 25, 2016

Last Update Submitted That Met QC Criteria

July 14, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C6958-R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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