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Maria A Parker, Laura R Erker, Dongseok Choi, Mark E Pennesi, Richard G Weleber, David J Wilson; Test-Retest Variability of Functional and Structural Parameters in patients with ABCA4-related retinopathy. Invest. Ophthalmol. Vis. Sci. 2016;57(12):5159.
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© ARVO (1962-2015); The Authors (2016-present)
There is currently very limited information regarding the test re-test variability in patients with ABCA4-related retinopathy (Stargardt Disease), the most common form of juvenile autosomal recessive macular dystrophy. The goal of this analysis is to analyse test re-test variability of functional and structural measures that can be used to assess safety and efficacy in patients with Stargardt Disease (STGD) participating in clinical trials.
Twenty two participants aged 25-66 diagnosed with STGD, with at least one pathogenic ABCA4 mutation on each chromosome, were evaluated over three visits within three weeks or less (NCT01367444). Functional visual evaluations included. Best Corrected Visual Acuity (BCVA) ETDRS letter score, kinetic visual field (KVF) isopters I4e, III4e and V4e, hill of vision (HOV) calculated from static visual fields by using 184n grid with the size V test target. Retinal structural changes were assessed by spectral domain optical coherence tomography (SD-OCT). Repeatability coefficients (RC) and 95% confidential intervals (CI) were calculated for each parameter by using hierarchical mixed-effects model and bootstrapping.
The criteria of statistically significant changes were the following: BCVA (8 letter score), KVF isopters I4e, III4e and V4e (3478.85; 2488.02 and 2622.46 dg2 respectively), full HOV (14.62 dB-sr), central macular thickness and macular volume (4.27 μm and 0.15 mm3 respectively). The RCs and associated CIs are summarized in Table 1.
Conclusions: This analysis provides important information necessary to determine if significant changes are occurring in structural and functional outcomes. Moreover, this information is essential to assess efficacy and safety in treatment trials involving STGD patients.
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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