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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00958360
First received: August 11, 2009
Last updated: July 14, 2016
Last verified: July 2016
Results First Received: May 27, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Central Vision Loss From Macular Diseases
Interventions: Other: Interdisciplinary Low Vision Service
Other: Basic Low Vision Service

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 2,051 patients were screened, of whom 1,728 were excluded (1,706 ineligible per chart review and 22 ineligible after screening).

Reporting Groups
  Description
Interdisciplinary Low Vision Rehabilitation Group

Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.

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.

Basic Low Vision Care Group

Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.

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.


Participant Flow:   Overall Study
    Interdisciplinary Low Vision Rehabilitation Group     Basic Low Vision Care Group  
STARTED     163     160  
COMPLETED     152     150  
NOT COMPLETED     11     10  
Withdrawal by Subject                 3                 1  
Death                 6                 7  
Physician Decision                 2                 1  
Lost to Follow-up                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Interdisciplinary Low Vision Rehabilitation Group

Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.

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.

Basic Low Vision Care Group

Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.

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.

Total Total of all reporting groups

Baseline Measures
    Interdisciplinary Low Vision Rehabilitation Group     Basic Low Vision Care Group     Total  
Number of Participants  
[units: participants]
  163     160     323  
Age  
[units: years]
Mean (Standard Deviation)
  80.1  (10.8)     79.2  (10.1)     79.7  (10.5)  
Gender  
[units: participants]
     
Female     5     4     9  
Male     158     156     314  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     6     8     14  
Not Hispanic or Latino     157     152     309  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     6     6  
Black or African American     15     10     25  
White     148     144     292  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Joan Stelmack, O.D., M.P.H.
Organization: Hines VA Blind Center
phone: 708-202-2124
e-mail: joan.stelmack@va.gov


Publications:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00958360     History of Changes
Other Study ID Numbers: C6958-R
Study First Received: August 11, 2009
Results First Received: May 27, 2016
Last Updated: July 14, 2016
Health Authority: United States: Federal Government