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James Loughman, Michael Moore, Daniel Ian Flitcroft; Myopia Progression Centiles from Real World Data: An Ecologically Valid Tool for Myopia Treatment Efficacy Monitoring?. Invest. Ophthalmol. Vis. Sci. 2020;61(7):79.
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Control group data from randomized controlled trials has been proposed as a basis for predicting myopic progression, yet clinical trials may not reflect “real-world" progression due to recruitment biases. The most ecologically valid data source for predicting myopic progression in the ‘real world’ are patients from clinical practice, refracted according to practice norms. This study was designed to determine the natural history of myopic progression using electronic medical record data from community optometric practices in European children.
An anonymized but unselected sample of electronic medical records (EMR) containing non-cycloplegic refraction data for 243,310 unique subjects were used to compute spherical equivalent refractive error (SERE). Of these, 40,643 unique subjects were aged ≤18. Gender and age specific population centiles for annual myopic progression were derived from a non-linear optimization model based on SERE progression data for the subset of myopic children (SERE ≤ -0.50D) who presented for multiple clinical practice visits with a 6 to 18 month window between visits (n=7733).
The median (50th) centile of myopic progression increased from -0.07 D/year at age 5 to a peak of -0.50 D/year at age 8, and then declined to -0.19 D/yr by age 18. The lowest quartile (< 25th centile) showed minimal progression, but the higher quartiles showed much faster progression that peaked at age 7 (75th centile = -0.97 D/year, 90th centile = -1.82 D/year). In comparison, the control groups of 13 Western myopia control trials (published from 1989-2019, n = 1045) showed a mean progression of -0.54D/year. Age-specific predictions of progression calculated for each RCT showed a mean progression -0.15 D/yr (range -0.71 to 0.23D/yr) faster than observed in the EMR data. Progression centiles for the RCT’s showed faster than the median progression observed in clinical practice, median RCT progression centile = 61.45 (95%CI: 52.9 to 70.0).
The use of real world myopia progression data to produce population progression centiles provides a viable solution for myopia treatment monitoring. The use of clinical trial data, in comparison, lacks ecological validity and cannot be generalized to predict myopia progression or monitor treatment efficacy in clinical practice.
This is a 2020 ARVO Annual Meeting abstract.
Figure 1: EMR Myopia Progression centiles and RCT control group annualized progression
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