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Diabetic Retinopathy And the Myvisiontrack™ App (DRAMA) Study

This study is currently recruiting participants.
Verified April 2013 by Vital Art and Science Incorporated
Sponsor:
Collaborators:
National Eye Institute (NEI)
Retina Foundation of the Southwest
University of Texas Southwestern Medical Center
Texas Retina Associates
Information provided by (Responsible Party):
Vital Art and Science Incorporated
ClinicalTrials.gov Identifier:
NCT01728883
First received: November 13, 2012
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to determine the effect of enhancements to the myVisionTrack™ in regards to patient compliance and test-retest variability. Additionally, the ability of myVisionTrack™ to detect changes in vision function will be evaluated.

The results of this study will provide the basis for patient self-monitoring of visual function with the myVisionTrack™, and for reporting, storage, and maintenance of collected data. The myVisionTrack™ is intended to be used remotely by patients to monitor their disease. In the case of significant changes, patients will be prompted to visit their ophthalmologist. It is hypothesized that this can lead to earlier detection of disease progression, which, in turn, can lead to earlier treatment and better prevention against vision loss due to diabetic retinopathy (DR).


Condition Intervention
Diabetic Retinopathy
Diabetic Macular Edema
 Device: Home vision monitoring using myVisionTrack(TM)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of New Self-Test Visual Function Assessment System for Diabetic Retinopathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vital Art and Science Incorporated:

Primary Outcome Measures:
  • Test efficacy of the test algorithm improvements [ Time Frame: Twelve months ] [ Designated as safety issue: No ]
    To test the efficacy of test algorithm improvements and usability enhancements on the overall rate of patient compliance and on test-retest variability.


Secondary Outcome Measures:
  • Refine the decision rule [ Time Frame: Twelve months ] [ Designated as safety issue: No ]
    To refine the decision rule so as to select optimal cutoff values to achieve desired sensitivity and specificity of self-test

  • Can improved testing algorithm minimize test time? [ Time Frame: Twelve months ] [ Designated as safety issue: No ]
    To determine if the improved testing algorithm can minimize the length of testing while maintaining or improving accuracy

  • Assess patient satisfaction with the test [ Time Frame: Twelve months ] [ Designated as safety issue: No ]
    To assess patient satisfaction regarding the use of myVisionTrack™


Estimated Enrollment: 100
Study Start Date: April 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Home vision monitoring using myVisionTrack(TM)
Patients diagnosed with diabetic retinopathy/diabetic macular edema requiring treatment at the time of recruitment into the study.
 Device: Home vision monitoring using myVisionTrack(TM)
Patients will be asked to test their vision at home twice per week using myVisionTrack(TM) during the study period.
Other Name: myVisionTrack(TM) Model 0004

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with diabetic retinopathy requiring treatment

Criteria

Inclusion Criteria:

  • DR requiring treatment at time of study initiation
  • Macular edema involving the central subfield based on clinical judgment
  • No noticeable central subfield atrophy
  • Patients willing and able to comply with all study and follow-up procedures (including the handling of the myVisionTrack™ device)

Exclusion Criteria:

  • Any ocular pathology other than DR
  • Any other concurrent systemic illness affecting the retina and visual function
  • Dementia or other neurological or psychological limitation that would prevent patients from performing self-testing of visual function
  • Past (within the prior 6 months) or current use of, or likely need for, systemic medications that are known to be toxic to the lens, retina, or optic nerve
  • Use of investigational drugs at the time of screening, or within 60 days (excluding vitamins and minerals)
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01728883

Locations
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75284
Contact: Mike Molai     214-645-2014     Mike.Molai@UTSouthwestern.edu    
Principal Investigator: Yu-Guang He, MD            
Retina Foundation of the Southwest Not yet recruiting
Dallas, Texas, United States, 75231
Contact: Gina Mitzel, PhD            
Principal Investigator: Gina Mitzel, PhD            
Sponsors and Collaborators
Vital Art and Science Incorporated
National Eye Institute (NEI)
Retina Foundation of the Southwest
University of Texas Southwestern Medical Center
Texas Retina Associates
Investigators
Study Chair: Yi-Zhong Wang, PhD Retina Foundation of the Southwest
  More Information

No publications provided

Responsible Party: Vital Art and Science Incorporated
ClinicalTrials.gov Identifier: NCT01728883     History of Changes
Other Study ID Numbers: 2R44EY020016-03, 2R44EY020016
Study First Received: November 13, 2012
Last Updated: April 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vital Art and Science Incorporated:
Diabetic Retinopathy
Diabetic Macular Edema
Macular Edema
Maculopathy
 home monitoring
shape discrimination hyperacuity
Psychophysical Testing

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Edema
Macular Edema
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
 Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration

ClinicalTrials.gov processed this record on June 17, 2013