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Yi-Zhong Wang, Yu-Guang He, Karl G Csaky, Gina Mitzel, Karen Hernandez, Song Zhang, Michael B Bartlett; Diabetic Retinopathy And the MyVisionTrack® App (DRAMA) Study. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):516.
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It has been shown in a cross-sectional study (Wang, et al. IOVS 54:5497, 2013) that myVisionTrack® (mVTTM), a mobile shape discrimination hyperacuity (SDH) test, is sensitive to the severity of maculopathy. The goal of the DRAMA study (NCT01728883) was to assess the capability of mVTTM to detect visual function improvement associated with anti-VEGF treatments in patients with diabetic macular edema (DME).
A 12-month prospective longitudinal study was designed to recruit 44 DME patients. To date 33 DME patients (age 62.5±8.0SD yrs) were enrolled in the study. At enrollment, the study eye was under monthly to bi-monthly anti-VEGF injection treatments and had visual acuity (VA) 20/100 or better. Besides the standard care, SDH, VA and SD-OCT central subfield thickness (CST) were obtained at the baseline and every 3 months. The SDH self-test was implemented on an iPad using a spatial 4-alternative forced-choice staircase paradigm (Wang, et al. IOVS 2013 54:ARVO E-Abstract 5019). Clinical judgment of change (CJ-C) was assessed by the treating retinal specialist every 3 months.
For those patients who completed the 3-month visit (n=28), the mean±SD SDH of the study eyes improved from -0.22±0.21 to -0.33±0.21 logMAR (p<0.002). In comparison, mean VA (0.31±0.22 logMAR) and CST (349±114mm) at 3-month showed no significant change from the baseline (0.30±0.21 logMAR and 358±100 mm, respectively). For the patients who completed the 6-month visit (n=23), SDH of the study eyes improved from -0.21±0.20 to -0.33±0.22 logMAR (p<0.001), and CST reduced from 355±89 mm to 316±78 mm (p<0.007), while mean VA (0.29±0.21 logMAR) at 6-month showed no significant improvement from the baseline (0.33±0.21 logMAR). At 3-month, 50% of patients had CJ-C of improvement, with their SDH improved by 0.15±0.17 logMAR (p<0.006). At 6-month, 61% of patients had CJ-C of improvement, with their SDH improved by 0.13±0.18 logMAR (p<0.016) and CST reduced by 44±62 mm (p<0.019). Mean VA related to CJ-C showed no significant change at either 3- or 6-month.
Previous studies (Kaiser, et al. Retina, 33:1863, 2013; Wang, et al. IOVS 2014 55:ARVO E-Abstract 5602) demonstrated that patients with maculopathy had a high compliance of visual function self-testing at home using mVTTM. The interim results of the DRAMA study suggest that mVTTM can be a useful remote monitoring tool at home to track treatment effect and to detect disease condition changes.
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