Dec. 16, 2020 — A new study slated to appear in the January 2021 issue of Ophthalmic & Physiological Optics, the peer-reviewed journal of the UK College of Optometrists, has found very low complication rates in children who wear soft contact lenses, similar to rates in adults.
Robin Chalmers, O.D., FAAO, served as principal investigator, co-authoring the paper, titled “Adverse Event Rates in The Retrospective Cohort Study of Safety of Paediatric Soft Contact Lens Wear: the ReCSS Study,” with CooperVision scientists John McNally, O.D., FAAO, and Paul Chamberlain, BSc(Hons), and Lisa Keay, Ph.D, head of the School of Optometry and Vision Science for UNSW Sydney.
“ReCSS is the most extensive compilation of real-world data supporting safety of soft contact lens wear in children, complementing the effectiveness research from our groundbreaking, multi-year MiSight 1 day clinical study,” says Dr. McNally, CooperVision’s senior director of clinical research. “Practitioners will appreciate the fact that the study included a range of eyecare practice types and locations and a variety of soft contact lens brands, modalities, and designs. Parents should be even more confident in embracing the benefits of a soft contact lens-based approach to myopia management by knowing that the study evaluated the safety of contact lenses in children of the same age range as their own.”
The study was initiated to support CooperVision’s regulatory submissions of MiSight 1 day contact lenses, which are currently available in 26 countries, with more expected in 2021.
The MiSight 1 day contact lens was recently recognized by Popular Science magazine with the 2020 “Best of What’s New Award” in the health category. It is the first FDA-approved contact lens for slowing the progression of myopia in children, who at initiation of treatment, are 8-12 years of age. Additionally, CooperVision’s Brilliant Futures Myopia Management Program launched in the U.S. earlier this year, with actress and entrepreneur Sarah Michelle Gellar as the spokesperson for the program.
ReCSS measured the rate of adverse events (AE) in children who were prescribed soft contact lenses before they turned 13 years old to establish wearing safety among that age group. The review documented AE details from clinical practice charts and clinical trial data of nearly 1,000 children and observed 2,713 years of wear across 4,611 visits. Compared to AE results derived exclusively from clinical trials, these data are likely to be more generalizable to real world experiences as myopia control soft contact lenses are prescribed more widely to young patients.
Clinical records from office visits with potential AEs were independently reviewed by an adjudication panel to determine a consensus diagnosis. The current findings are very similar to, but slightly lower than, rates reported in previous studies of similar age groups, possibly attributed to the higher proportion of daily disposable lenses in the current study. The study found the annualized incidence rate of inflammatory events was less than 1% per year of wear. The majority of events were conjunctivitis or foreign body abrasions, reflective of this young population.
Additionally, the authors notes that the ReCSS study found a lower rate of microbial keratitis (7.4/10,000 years of wear) with a tighter confidence interval than other pediatric post‐market studies, offering reassurance to clinicians and parents of children regarding the safety of myopia control soft contact lenses. That rate is comparable to established rates of microbial keratitis in adults.