Overview

This trial is active, not recruiting.

Conditions diabetic retinopathy, diabetic macular edema
Treatment home vision monitoring using myvisiontrack®
Sponsor Vital Art and Science Incorporated
Collaborator National Eye Institute (NEI)
Start date April 2013
End date April 2016
Trial size 60 participants
Trial identifier NCT01728883, 2R44EY020016, 2R44EY020016-03

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
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®.
home vision monitoring using myvisiontrack® myVisionTrack® Model 0004
Patients will be asked to test their vision at home twice per week using myVisionTrack® during the study period.

Primary Outcomes

Measure
Test efficacy of the test algorithm improvements
time frame: Twelve months

Secondary Outcomes

Measure
Refine the decision rule
time frame: Twelve months
Can improved testing algorithm minimize test time?
time frame: Twelve months
Assess patient satisfaction with the test
time frame: Twelve months

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

Official title Evaluation of New Self-Test Visual Function Assessment System for Diabetic Retinopathy
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).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Vital Art and Science Incorporated.