Diabetic Retinopathy And the Myvisiontrack® (DRAMA) Study

NCT01728883 | Completed DMC

• 2 other identifiers: 2R44EY020016-032R44EY020016
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetic Retinopathy; Diabetic Macular Edema

Keywords

Diabetic Retinopathy; Diabetic Macular Edema; Macular Edema; Maculopathy; home monitoring; shape discrimination hyperacuity; Psychophysical Testing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Refine the decision rule

  Twelve months

• Can improved testing algorithm minimize test time?

  Twelve months

• Assess patient satisfaction with the test

  Twelve months

Study Arms (1)

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®

Interventions

Home vision monitoring using myVisionTrack® DEVICE

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

Also known as: myVisionTrack® Model 0004

Diagnosed DR/DME requiring treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diabetic retinopathy requiring treatment

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vital Art and Science Incorporated: lead
• National Eye Institute (NEI): collaborator
• Retina Foundation of the Southwest: collaborator
• University of Texas Southwestern Medical Center: collaborator
• Texas Retina Associates: collaborator

Study Sites (2)

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75284, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Macular Edema; Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Retinal Degeneration

Study Officials

• Yi-Zhong Wang, PhD

  Retina Foundation of the Southwest

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: November 20, 2012
• Study Start: April 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: March 1, 2017
• Last Updated: May 12, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

US (2)