Diabetic Retinopathy And the Myvisiontrack® (DRAMA) Study

Vital Art and Science Incorporated60 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Diabetic Retinopathy Diabetic Macular Edema

Interventions

Home vision monitoring using myVisionTrack®DEVICE

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

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (2)

Retina Foundation of the Southwest

Dallas, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

Test efficacy of the test algorithm improvements

To test the efficacy of test algorithm improvements and usability enhancements on the overall rate of patient compliance and on test-retest variability.

Time frame: Twelve months

Secondary Outcomes

Refine the decision rule

To refine the decision rule so as to select optimal cutoff values to achieve desired sensitivity and specificity of self-test

Time frame: Twelve months

Can improved testing algorithm minimize test time?

To determine if the improved testing algorithm can minimize the length of testing while maintaining or improving accuracy

Time frame: Twelve months

Assess patient satisfaction with the test

To assess patient satisfaction regarding the use of myVisionTrack™

Time frame: Twelve months

Data from ClinicalTrials.gov

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