Diabetic RetinopathyDRAMANCT01728883
Diabetic Retinopathy And the Myvisiontrack® (DRAMA) Study
An observational study of Diabetic Retinopathy and Diabetic Macular Edema, run by Vital Art and Science Incorporated at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetic Retinopathy, Diabetic Macular Edema
- What is being tested?
- Home vision monitoring using myVisionTrack®
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2013to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diabetic retinopathy requiring treatment
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Retina Foundation of the Southwest
Dallas, Texas, 75231
UT Southwestern Medical Center
Dallas, Texas, 75284
About this study
Official title: Evaluation of New Self-Test Visual Function Assessment System for Diabetic Retinopathy
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.
Read the 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).
- Conditions
- Diabetic Retinopathy, Diabetic Macular Edema
- Being tested
- Home vision monitoring using myVisionTrack®
- Keywords
- Diabetic Retinopathy, Diabetic Macular Edema, Macular Edema, Maculopathy, home monitoring, shape discrimination hyperacuity, Psychophysical Testing
- Medical subject headings
- Diabetic Retinopathy, Macular Edema, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home vision monitoring using myVisionTrack®Device
Also called myVisionTrack® Model 0004
Patients will be asked to test their vision at home twice per week using myVisionTrack® during the study period.
| Study group | Role | What they receive |
|---|---|---|
| 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®. Receives: Device: Home vision monitoring using myVisionTrack® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Twelve months
Secondary outcomes (3)
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
Measured: Twelve months
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
Measured: Twelve months
Assess patient satisfaction with the test
To assess patient satisfaction regarding the use of myVisionTrack™
Measured: Twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startApr 2013
- Primary completionApr 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vital Art and Science Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Eye Institute (NEI), Retina Foundation of the Southwest, University of Texas Southwestern Medical Center, Texas Retina Associates
- Responsible party
- Sponsor
- Investigators
- Yi-Zhong Wang, PhD, Study chair, Retina Foundation of the Southwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728883
- Sponsor's protocol ID
- 2R44EY020016-03
- Other IDs
- 2R44EY020016
- Acronym
- DRAMA
- Status last verified
- May 2017
- First submitted
- 13 Nov 2012
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: DME Monitoring Results presented at ARVO on May 2, 2016. Additional results planned.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of New Self-Test Visual Function Assessment System for Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT01728883
- Acronym / sponsor ID
- DRAMA / 2R44EY020016-03
- Conditions
- Diabetic Retinopathy, Diabetic Macular Edema
- Keywords
- Diabetic Retinopathy, Diabetic Macular Edema, Macular Edema, Maculopathy, home monitoring, shape discrimination hyperacuity, Psychophysical Testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vital Art and Science IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- National Eye Institute (NEI), Retina Foundation of the Southwest, University of Texas Southwestern Medical Center, Texas Retina Associates
- Study start
- Apr 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 20 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosed DR/DME requiring treatment | – | Device: Home vision monitoring using myVisionTrack®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®. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diabetic retinopathy requiring treatment
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home vision monitoring using myVisionTrack®Also: myVisionTrack® Model 0004Patients will be asked to test their vision at home twice per week using myVisionTrack® during the study period. | Device | Diagnosed DR/DME requiring treatment |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Individual participant dataSharing planned: Yes. DME Monitoring Results presented at ARVO on May 2, 2016. Additional results planned.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Zhong Wang, PhD study chair
Retina Foundation of the Southwest
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy and Diabetic Macular Edema, run by Vital Art and Science Incorporated at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test efficacy of the test algorithm improvements (time frame: Twelve months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2017; AzTrials last refreshed its copy on 6 Nov 2026.