Trial record 5 of 29 for:    Open Studies | "Vision, Low"

Low Vision Intervention Trial II (LOVIT II)

This study is currently recruiting participants.
Verified March 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00958360
First received: August 11, 2009
Last updated: March 13, 2014
Last verified: March 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 ]

Estimated Enrollment: 330
Study Start Date: August 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958360

Contacts
Contact: Nancy Ellis, MS (414) 384-2000 ext 41514 nancy.ellis2@va.gov

Locations
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   
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: March 13, 2014
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 April 17, 2014