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

August 11, 2009
August 15, 2014
August 2010
January 2015   (final data collection date for primary outcome measure)
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 ]
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 3 months later ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00958360 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Low Vision Intervention Trial II (LOVIT II)
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Central Vision Loss From Macular Diseases
  • 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
  • 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
  • Experimental: Arm 1
    Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.
    Intervention: Other: Interdisciplinary Low Vision Service
  • 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.
    Intervention: Other: Basic Low Vision Service
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
323
September 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00958360
C6958-R
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Joan Stelmack, OD MPH Edward Hines Jr. VA Hospital
Department of Veterans Affairs
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP