Diabetic Retinopathy And the Myvisiontrack® (DRAMA) Study

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Diabetic Retinopathy, Diabetic Macular Edema

Intervention / Treatment
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* Device: Home vision monitoring using myVisionTrack®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnosed DR/DME requiring treatment<br>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®<br>* Patients will be asked to test their vision at home twice per week using myVisionTrack® during the study period.<br>* Other names: myVisionTrack® Model 0004;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Twelve months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Twelve months | 
| Assess patient satisfaction with the test | To assess patient satisfaction regarding the use of myVisionTrack™ | Twelve months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Retinopathy, Diabetic Macular Edema, Macular Edema, Maculopathy, home monitoring, shape discrimination hyperacuity, Psychophysical Testing