MiSight 1-day myopia control lenses effective in real-world comparison
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Analysis of the MiSight 1-day trial compared with clinical practice results showed an effective change in the natural history of myopia with a reduction in the proportion of fast progressors among both younger and older wearers.
Daniel Flitcroft, MBBS, PhD, from the Children’s University Hospital in Dublin, Ireland, began his virtual ARVO presentation by addressing the differences between clinical trials and clinical practice, specifically that outcomes in the former are based on average results and success, whereas the latter is based on individual patients. Additionally, there can be up to 17 years of lag between first evidence and what becomes standard practice.
“In clinical trials, there are fixed protocols, so there is no adjustment of treatment during the trial. For every visit in clinical practice, we have to evaluate and judge whether to continue, modify or discontinue treatment,” Flitcroft said.
Flitcroft and colleagues calculated age- and sex-specific population centiles of refraction and annual progression for the 113 patients recruited to the MiSight 1-day (CooperVision) trial at Western trial sites. The reference population comprised 4,650 Irish children 8 to 17 years old from anonymized optometric health records.
Patients in the trial control group had no significant change in centile values of spherical equivalent refraction compared with the population sample, whereas the treatment group showed a change of –10.7 (95% CI, –12.7 to –8.7). Similarly, the treatment group had a significantly lower mean progression centile value (32.6 in year 1; 95% CI, 26.9-38.4) that persisted during the 3-year trial, while the control group had results similar to the population sample (58.4; 95% CI, 53.3-63.5).
Based on histograms of progression centiles, results showed that the treatment group had a reduction in fast progressors among both younger (treatment vs. control; P < .00001) and older patients (treatment vs. control; P < .0005).
Flitcroft concluded that the control group’s progression patterns were typical of that seen in clinical practice. In comparison, the natural history of myopia progression was changed with MiSight lens wear, with a significant shift to lower-than-expected age-matched progression rates.
“This [analysis] approach showed that the benefit was not seen in everyone, not everyone achieved the average results, but this helps us to identify those patients who are likely to respond and those who are not likely to respond,” he said. “In clinical practice, this is a very useful distinction.”
Reference:
- Chamberlain P, et al. Optom Vis Sci. 2019;doi:10.1097/OPX.0000000000001410.