Diabetic Retinopathy And the Myvisiontrack® (DRAMA) Study

Diabetic Retinopathy Clinical Trial

— DRAMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01728883
• Other study ID #: 2R44EY020016-03
• Secondary ID: 2R44EY020016
• Status: Completed
• Phase: N/A
• First received: November 13, 2012
• Last updated: May 11, 2017
• Start date: April 2013
• Est. completion date: March 2017

Study information

• Verified date: May 2017
• Source: Vital Art and Science Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Diabetic Retinopathy
• Macular Edema
• Retinal Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Retina Foundation of the Southwest	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (5)

Lead Sponsor	Collaborator
Vital Art and Science Incorporated	National Eye Institute (NEI), Retina Foundation of the Southwest, Texas Retina Associates, University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Assess patient satisfaction with the test	To assess patient satisfaction regarding the use of myVisionTrack™	Twelve months