Evaluation of New Self-Test Visual Function Assessment System for Diabetic Retinopathy (Phase II - DRAMA Study)
This methodological open-label study is designed to evaluate the usability of a handheld device (mVT[TM]) to remotely monitor and access vision function in standard clinical practice. All patients will receive the device and training through their site personnel. This study is designed as a single arm, double-blind study. Patients are blinded to the results of their self-tests to avoid biasing future test results as well as any self-assessment questionnaires. Investigators and patients[Right Quote] retinal specialists are blinded to mVT test results (both self-testing and in-lab testing), so that their evaluation of disease status is not affected by mVT scores.The duration of the study will be 12 months for the patient.
* Demographics - Age, DOB, Race, Sex, Ethnicity
* Concomitant Medication - Systemic use of prescribed medications and supplement use
* Ophthalmic/Systemic history - Diagnosed conditions
* mVT[TM] - My Vision Track shape discrimination assessments performed on the iPad2
* BCVA - Best Corrected Visual Acuity performed with glasses to determine distance vision visual potential
* PRCS - PRCS testing will be assessed using PRCS charts at a testing distance of 1 meter after performing full refraction. Each eye will be tested separately, followed by testing of both eyes simultaneously, for a total of three tests. The contrast sensitivity score will be recorded in the CRF.
* R28 - Roth 28-Hue test uses every third color cap from the Farnsworth-Munsell 100-hue (85-color-cap) test. The result of the Roth 28-Hue test will be recorded on the appropriate CRF page.
* Paper AG - Paper Amsler Grid (Paper AG) testing will be performed at a distance of 12 inches. Each eye will be tested separately, and results will be recorded in the CRF.
* Desktop SDH - Radial frequency (RF) patterns are used as stimuli. The contour of RF patterns has a cross-sectional luminance profile of the fourth derivative of Gaussian, which is band limited in the spatial frequency domain. The main parameters describing an RF pattern include mean radius (i.e., the radius of the un-deformed RF pattern), RF (the number of modulation cycles per circumference), amplitude of radial modulation (the amount of deformation), peak spatial frequency of RF patterns (determining the width of the contour), and stimulus contrast. The radial deformation is introduced by sinusoidally modulating the radius.
A spatial two-alternative forced-choice (2AFC) paradigm and a temporal 2AFC paradigm are used. For the spatial 2AFC, a deformed RF pattern is paired with an un-deformed RF pattern on each trial. The subject is asked to indicate which pattern is deformed.
* OCT - Spectral Domain OCT must be performed at visits indicated in Table 6-1 on both eyes. Central Retinal Subfield Thickness and other features will be evaluated to determine DR disease activity. For consistency of the OCT data collected, the same SD-OCT device must be used for an individual patient throughout the study. The investigator must use the cube scan to evaluate the required OCT data. Please refer to the user manual of the OCT scanner for instructions on obtaining the scan.
* Color fundus photography - Following dilation, the retina will be photographed to document macular and peripheral retina for signs of change
* Dilated ophthalmoscopy - A standard dilated ophthalmic examination, and slit lamp biomicroscopy will be performed on both eyes at all visits. The results of the dilated ophthalmoscopy will be recorded in the source documents and clinically significant abnormalities will be recorded on the CRF.
* CJ-C scale - comprises the results of all available assessments summarized as one clinical judgment of change.
* Patient Satisfaction - At the end of the study, patient[AND]amp;apos;s will be given a satisfaction questionnaire to gauge the usability of the mVT[TM] device.
1) Aged 21 years or older;
2) Requires treatment for DR at time of study recruitment;
3) Macular edema involving the central macula based on clinical judgment;
4) Best Corrected Visual Acuity (BCVA x Snellen assessed by glasses and/or contact lenses) of the study eye 20/100 or better with potential of vision recovery due to stand of care treatment;
5) Patients willing and able to comply with all study and follow-up procedures (including the handling of the mVT(TM) device);
6) If patient is of reproductive potential, and agrees to remain abstinent or to use (or to have their partner use) an acceptable method of birth control for the duration of the study
7) Written informed consent obtained before any assessment is performed.
Identification of the
* study eye
Once a patient has been identified as meeting the Inclusion/Exclusion criteria the Study doctor will also identify which of the patient[Single Quote]s eyes will be identified as the
* study eye
* for the purposes of this Study. The following criteria will be used to identify the study eye.
The study eye should have:
(1) 20/100 or better
(2) Need treatment now
(3) If both eyes need treatment and are with VA 20/100 or better, select the eye with worse VA as the study eye (or as determined by the study doctor for the reason that it may have higher chance for improvement, etc.)
(4) If both eyes need treatment and are with the same VA 20/100 or better, then choose OS as the study eye (or as determined by the study doctor for the reason that it may have higher chance for improvement, etc.)
The rationale for such selection criteria is to maximize the VA range for the study eyes.