Diabetic Retinopathy And the Myvisiontrack® (DRAMA) Study

Vital Art and Science

Status: Completed

Conditions: Diabetic Macular Edema; Diabetic Retinopathy

Treatments: Device: Home vision monitoring using myVisionTrack®

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT01728883

2R44EY020016-03

2R44EY020016 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 40+ years old

Volunteers: No 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

Trial design

60 participants in 1 patient group

Diagnosed DR/DME requiring treatment

Description:

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®.

Treatment:

Device: Home vision monitoring using myVisionTrack®