The Safety of Soft Contact Lenses in Children

Abstract

PurposeThere is increasing interest in fitting children with soft contact lenses. This review collates data from a range of studies to estimate the incidence of complications, specifically corneal infiltrative events and microbial keratitis, in patients under the age of 18 years.MethodsPeer-review papers were identified using PubMed and the Web of Science. A broad range of studies are summarized including large-scale epidemiological studies of contact lens–related complications, hospital-based case series, long- and short-term prospective studies, and multicenter retrospective studies.ResultsNine prospective studies representing 1800 patient years of wear in 7- to 19-year-olds include safety outcomes. In three large prospective studies representing between 159 and 723 patient years of soft contact lens wear in patients 8 to 14 years, the incidence of corneal infiltrative events is up to 136 per 10,000 years. Data from a large retrospective study show similar rates of corneal infiltrative events: 97 per 10,000 years in 8- to 12-year-olds (based on 411 patient years of wear) and 335 per 10,000 years in 13- to 17-year-olds (based on 1372 patient years of wear). None of the prospective studies report any cases of microbial keratitis. Five clinical studies where safety data are not reported constitute a further 493 patient years. One retrospective study found no cases of microbial keratitis occurred in 8- to 12-year-olds (411 patient years) and an incidence of 15 per 10,000 patient years in 13- to 17-year-olds (1372 patient years)—no higher than the incidence of microbial keratitis in adults wearing soft contact lenses on an overnight basis.ConclusionsThe overall picture is that the incidence of corneal infiltrative events in children is no higher than in adults, and in the youngest age range of 8 to 11 years, it may be markedly lower.

Epidemiology of contact lens‐induced infiltrates: an updated review

“…In a recent review examining the safety of contact lenses in children, Bullimore reported the overall incidence rate of CIEs in children aged seven to 17 years as zero–335 per 10,000 years of contact lens wear . This is less than the reported annualised incidence of symptomatic CIEs in adults that ranged from 316–2,061 per 10,000 patient‐years . This relationship agrees well with the incidence of 97 per 10,000 years found by the CLAY study when they looked specifically at an eight to 12‐year‐old population .…”

“…However, this finding does not hold true for the youngest contact lens wearers. In a recent review examining the safety of contact lenses in children, Bullimore reported the overall incidence rate of CIEs in children aged seven to 17 years as zero–335 per 10,000 years of contact lens wear . This is less than the reported annualised incidence of symptomatic CIEs in adults that ranged from 316–2,061 per 10,000 patient‐years .…”

Myopia Control 2020: Where are we and where are we heading?

“…These findings were confirmed by a comprehensive review of prospective studies of soft contact lens wear in young children 95 . Six published studies were identified with at least 150 patient years of lens wear reporting safety outcomes 18,72,82,108,126,127 .…”

IMI – Industry Guidelines and Ethical Considerations for Myopia Control Report

“…91 Although the latter may be theoretically possible with the off-label use of contact lenses in children, recent studies have shown that children do not have a higher risk than adults of suffering from contact lens-related complications with either OK 92,93 or soft contact lens wear. 94 Based on their relative safety profile [92][93][94][95] and significant levels of MC efficacy reported in the scientific literature, 13,15,17,96 OK and multifocal soft contact lenses appear to represent a viable MC treatment option for children.…”

“…There is evidence in the literature for certain devices having a role as being effective 12,13,17,96,129 and relatively safe [92][93][94][95] in reducing myopia progression. Ultimately, MC efficacy should be demonstrated in controlled clinical studies on human participants and confirmed by regulatory bodies to obtain marketing authorization or by independent research laboratories in case of off-label/unlicensed treatments, rather than basing claims of MC on extrapolation of results from animal studies or presumption of equivalence.…”