Diabetic Retinopathy And the Myvisiontrack® (DRAMA) Study (DRAMA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01728883|
Recruitment Status : Completed
First Posted : November 20, 2012
Last Update Posted : May 12, 2017
|Condition or disease||Intervention/treatment|
|Diabetic Retinopathy Diabetic Macular Edema||Device: Home vision monitoring using myVisionTrack®|
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Official Title:||Evaluation of New Self-Test Visual Function Assessment System for Diabetic Retinopathy|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||March 2017|
Diagnosed DR/DME requiring treatment
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®
Patients will be asked to test their vision at home twice per week using myVisionTrack® during the study period.
Other Name: myVisionTrack® Model 0004
- Test efficacy of the test algorithm improvements [ Time Frame: Twelve months ]To test the efficacy of test algorithm improvements and usability enhancements on the overall rate of patient compliance and on test-retest variability.
- Refine the decision rule [ Time Frame: Twelve months ]To refine the decision rule so as to select optimal cutoff values to achieve desired sensitivity and specificity of self-test
- Can improved testing algorithm minimize test time? [ Time Frame: Twelve months ]To determine if the improved testing algorithm can minimize the length of testing while maintaining or improving accuracy
- Assess patient satisfaction with the test [ Time Frame: Twelve months ]To assess patient satisfaction regarding the use of myVisionTrack™
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01728883
|United States, Texas|
|Retina Foundation of the Southwest|
|Dallas, Texas, United States, 75231|
|UT Southwestern Medical Center|
|Dallas, Texas, United States, 75284|
|Study Chair:||Yi-Zhong Wang, PhD||Retina Foundation of the Southwest|