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James S. Wolffsohn, Pete S. Kollbaum, David A. Berntsen, David A. Atchison, Alexandra Benavente, Arthur Bradley, Hetal Buckhurst, Michael Collins, Takashi Fujikado, Takahiro Hiraoka, Masakazu Hirota, Debbie Jones, Nicola S. Logan, Linda Lundström, Hidemasa Torii, Scott A. Read, Kovin Naidoo; IMI – Clinical Myopia Control Trials and Instrumentation Report. Invest. Ophthalmol. Vis. Sci. 2019;60(3):M132-M160. doi: https://doi.org/10.1167/iovs.18-25955.
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The evidence-basis based on existing myopia control trials along with the supporting academic literature were reviewed; this informed recommendations on the outcomes suggested from clinical trials aimed at slowing myopia progression to show the effectiveness of treatments and the impact on patients. These outcomes were classified as primary (refractive error and/or axial length), secondary (patient reported outcomes and treatment compliance), and exploratory (peripheral refraction, accommodative changes, ocular alignment, pupil size, outdoor activity/lighting levels, anterior and posterior segment imaging, and tissue biomechanics). The currently available instrumentation, which the literature has shown to best achieve the primary and secondary outcomes, was reviewed and critiqued. Issues relating to study design and patient selection were also identified. These findings and consensus from the International Myopia Institute members led to final recommendations to inform future instrumentation development and to guide clinical trial protocols.
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