Clinical trial NCT01728883: Diabetic Retinopathy And the Myvisiontrack® (DRAMA) Study
Official title: Evaluation of New Self-Test Visual Function Assessment System for Diabetic Retinopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Diabetic Macular Edema
Keywords: Diabetic Retinopathy
Diabetic Macular Edema
Macular Edema
Maculopathy
home monitoring
shape discrimination hyperacuity
Psychophysical Testing
Lead sponsor: Vital Art and Science Incorporated
Sponsor class: INDUSTRY
Collaborators: name: National Eye Institute (NEI)
name: Retina Foundation of the Southwest
name: University of Texas Southwestern Medical Center
name: Texas Retina Associates
First posted: 2012-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diabetic retinopathy requiring treatment

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Test efficacy of the test algorithm improvements
timeFrame: Twelve months
Secondary outcomes:
measure: Refine the decision rule
timeFrame: Twelve months
measure: Can improved testing algorithm minimize test time?
timeFrame: Twelve months
measure: Assess patient satisfaction with the test
timeFrame: Twelve months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: Retina Foundation of the Southwest
name: Yi-Zhong Wang, PhD
role: STUDY_CHAIR
References: