Diabetic Retinopathy And the Myvisiontrack® (DRAMA) Study

Sponsor

Vital Art and Science Incorporated (Industry)

Overall Status

Completed

CT.gov ID

NCT01728883

Collaborator

National Eye Institute (NEI) (NIH), Retina Foundation of the Southwest (Other), University of Texas Southwestern Medical Center (Other), Texas Retina Associates (Other)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy Diabetic Macular Edema	Device: Home vision monitoring using myVisionTrack®

Detailed Description

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).

Study Design

Study Type:

Observational

Actual Enrollment :

60 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Evaluation of New Self-Test Visual Function Assessment System for Diabetic Retinopathy

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Diagnosed DR/DME requiring treatment Patients diagnosed as diabetic retinopathy(DR) and/or diabetic macular edema (DME) and requiring treatment at the time they are recruited into the Study. Patients will be home vision monitoring using myVisionTrack®.	Device: Home vision monitoring using myVisionTrack® Patients will be asked to test their vision at home twice per week using myVisionTrack® during the study period. Other Names: myVisionTrack® Model 0004

Arm

Intervention/Treatment

Diagnosed DR/DME requiring treatment

Patients diagnosed as diabetic retinopathy(DR) and/or diabetic macular edema (DME) and requiring treatment at the time they are recruited into the Study. Patients will be home vision monitoring using myVisionTrack®.

Device: Home vision monitoring using myVisionTrack®

Patients will be asked to test their vision at home twice per week using myVisionTrack® during the study period.

Other Names:

myVisionTrack® Model 0004

Outcome Measures

Primary Outcome Measures

Test efficacy of the test algorithm improvements [Twelve months]
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 [Twelve months]
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? [Twelve months]
To determine if the improved testing algorithm can minimize the length of testing while maintaining or improving accuracy
Assess patient satisfaction with the test [Twelve months]
To assess patient satisfaction regarding the use of myVisionTrack™

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

DR or AMD 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 or AMD
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