Diabetic Retinopathy And the Myvisiontrack® (DRAMA) Study

Completed

• Conditions: Diabetic Retinopathy; Diabetic Macular Edema
• Interventions: Device: Home vision monitoring using myVisionTrack®

• Registration Number: NCT01728883
• Lead Sponsor: Vital Art and Science Incorporated

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.

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 Timeline

• Study First Submitted: 2012-11-13
• Study First Submitted QC: 2012-11-13
• Study First Posted: 2012-11-20
• Study Start: 2013-04
• Primary Completion: 2016-04
• Study Completion: 2017-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-11
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diagnosed DR/DME requiring treatment	Home vision monitoring using myVisionTrack®	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®.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
Assess patient satisfaction with the test	Twelve months	To assess patient satisfaction regarding the use of myVisionTrack™

Trial Locations

Locations (2)

Retina Foundation of the Southwest; 🇺🇸 Dallas, Texas, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States