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Yi-Zhong Wang, Yu-Guang He, Karl G Csaky, Luis Rodriguez, Paulina Mejia, Song Zhang, Michael B Bartlett; Shape Discrimination Hyperacuity (SDH) Improvement After Treatment of Diabetic Macular Edema (DME): One-Year Results of the DRAMA Study. Invest. Ophthalmol. Vis. Sci. 2016;57(12):No Pagination Specified. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
The Diabetic Retinopathy And the MyVisionTrack® (mVTTM) App (DRAMA) study (NCT01728883) was designed to evaluate the feasibility of a handheld SDH test mobile app to assess visual function improvement associated with DME treatment. Here we report 1-year results of the DRAMA study.
Thirty-three patients with DME were recruited prospectively. At enrollment, the study eye was under active anti-VEGF treatments. Besides the standard care, SDH, visual acuity (VA) and SD-OCT central subfield thickness (CST) were obtained at the initial study visit 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). A linear mixed model was employed to assess SDH/VA changes associated with number of treatment over each 3-month period with the data from 20 patients, who completed the 1-year study and showed no significant CST worsening as defined by < 8 μm increase of CST at both 3 and 6 months (Comyn et al. IOVS 2012 53:7754).
SDH, VA and CST at the initial visit were -0.22±0.18SD logMAR, 0.30±0.17 logMAR, and 360±78 μm, respectively. The average numbers of treatment per patient within each 3-month period from the initial visit were 1.9, 1.1, 0.8, and 0.5, respectively. SDH improved significantly to -0.33±0.19 logMAR at 3 months (p<0.003), which was associated with the number of treatment (p<0.018). SDH continued showing significant improvement at 6 (p<0.002) and 9 months (p<0.023) compared to the initial visit, but the changes at these two 3-month periods were not significantly associated with the number of treatment. SDH at 12 months (-0.30±0.25 logMAR) was not significantly different from the initial visit. VA showed no significant change over the 1-year period. CST at 3, 6, 9 months showed significantly improvement vs. the initial visit (p<0.004). At 12 months, CST (337±108 μm) was borderline worse than at 9 months (301±77 μm, p=0.059). This 3-month change was associated with the number of treatment in the same period (p<0.007).
These results suggest that SDH may be able to reveal visual function improvement associated with anti-VEGF treatments for DME while visual acuity fails to document. mVTTM can be a useful self-testing tool at home to track treatment effect and to detect disease condition changes for patient with DME.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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