Adverse event rates in the retrospective cohort study of saf
Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...
The efficacy of myopia control soft contact lenses to slow the progression of myopia has been demonstrated, the US Food & Drug Administration (FDA) approved the first soft contact lens indicated to slow the progression of myopia in children who, at the initiation of treatment, are 8–12 years of age. These developments will increase the use of myopia control soft contact lenses around the world. Clinical prescribing of soft contact lenses as a myopia control strategy will continue to increase overall soft contact lens use in children, starting at 8–12 years of age as they experience the onset of myopia.

Despite well established information on the safety of soft contact lens in adults, the rate of serious adverse events with soft contact lens use in this younger age group has not been widely studied, since there was no specific indication for their use in the pediatric population before the introduction of myopia control soft contact lenses. Microbial keratitis (MK) related to soft contact lens wear is the most serious AE experienced by soft contact lens wearers, and in some instances may be sight-threatening. A study was conducted to ascertain the safety of soft contact lens wear in children through a retrospective chart review including real-world clinical practice settings.

The study encompassed 2713 years of wear and 4611 contact lens visits. The cohort was 46% male, 60% were first fitted with daily disposable soft contact lenses, the average age at first fitting was 10.5 years old, with a mean of 2.8 ± 1.5 years of wear of follow-up observed. There were 122 potential ocular adverse events observed from 118/963 subjects; the annualized rate of non-infectious inflammatory adverse events was 0.66%/year and 0.48%/year for contact lens papillary conjunctivitis. After adjudication, two presumed or probable microbial keratitis (MK) cases were identified, a rate of 7.4/10 000 years of wear. Both were in teenage boys and one resulted in a small scar without loss of visual acuity.

The summary of non-significant AEs experienced by these young wearers shows a relatively high rate of conjunctivitis (19 cases) and abrasion/foreign body events (14 cases), which seem reasonable in a sample of school-aged children. These AE results show the safety outcomes primarily derived from routine eye care practice visits and not exclusively from clinical trials with frequent defined visits; most of these youngsters received eye examinations approximately annually, and only presented for interim visits when they experienced problems. Compared to safety results derived exclusively from clinical trials, these results are likely to be more generalizable to the post market experience after myopia control soft contact lenses are prescribed more widely to young patients in practice.

These results give assurance of an acceptable range of safety during soft contact lens wear in children which will be reinforced with teaching protocols that emphasize best practices for safe soft contact lens wear. Much of the safety discussion amongst myopia control researchers promote the potential long term safety implications of reduced retinal disease and other sight-threatening ocular abnormalities if higher levels of myopia can be avoided; although it may be difficult for families and eye care practitioners to imagine that far into the future. The results of the current study help to answer parents’ and practitioners' concerns about the risk/benefit of real-world soft contact lens use in children and young teens and assure the relative safety of soft contact lens use in this age group.

Source:https://onlinelibrary.wiley.com/doi/10.1111/opo.12753
Like
Comment
Share