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Jill C. Kubiak, Amitha Domalpally, James White, Jacquelyn Freund, Ronald P. Danis; Automated Analysis for Evaluating Change in Central Subfield Thickness in Clinical Trials for Neovascular Age-Related Macular Degeneration (NVAMD). Invest. Ophthalmol. Vis. Sci. 2011;52(14):3694.
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© ARVO (1962-2015); The Authors (2016-present)
Change in central subfield thickness (CSF) is an important outcome for clinical trials. SDOCT software tools such as macular change analysis (Cirrus-Zeiss) recenter the grid based on previous visits so as to provide CSF change at the same point over time. The purpose of this study was to assess the benefit of automated macular change analysis software tool in determining CSF change in Reading Center (RC) evaluation for clinical trials for eyes with NVAMD.
Standard of care OCT scans of 43 subjects with NVAMD with at least 1 follow-up visit were evaluated using 4 different methods : (1) no RC evaluation-CSF values from the map report were utilized without quality assessment (2) RC evaluation-traditional RC method where quality assessment is performed with evaluator masked to follow-up visits (3) Automated macular change analysis (Cirrus-Zeiss)-software tool which adjusts grid (foveal) centration based on previous visits (4) Automated macular change analysis with RC quality check.
The mean (SD) CSF at baseline was 304.0 (94.4) µ without RC evaluation and 300.9 (94.2) with RC quality evaluation. The mean CSF at follow-up was 298.6 (102.5) µ without RC evaluation and 302.4 (113.9) with RC evaluation. The mean absolute change in CSF without RC evaluation was 49.5 (49.2) µ, and was 46.9 (42.7) µ with RC evaluation (p=0.56). The CSF change between the 2 methods varied by > 20 µ in 11 (25%) of subjects.The mean CSF change using automated macular change analysis software alone was 43.7 (37.3) µ and with RC quality check was 41.9 (39.1) µ (p=0.69). The CSF change using the software with and without RC evaluation varied by >20 µ in 8 (19%) of subjects.
Combining quality evaluation with automated change analysis tools provides the most accurate way of measuring CSF change over time.
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