Ocular health of children wearing daily disposable contact lenses over a 6-year period

Abstract

To report on the ocular health and safety of children fit with soft hydrogel daily-disposable contact lenses, and followed for 6-years in a double-masked clinical trial investigating the performance of a dual-focus contact lens designed to control myopia progression. Methods: Children aged 8− 12 years, naïve to contact lens wear, were enrolled across four international sites. During years 1-3, children were randomised to either MiSight® 1 day or Proclear® 1 day (both omafilcon A, CooperVision, Inc.). The lenses were identical in material and geometry except for the front optical zone design. At the end of year-3, all those wearing Proclear 1 day were switched to MiSight 1 day, therefore all wore MiSight 1 day in years 4− 6. Subjects agreed to wear the lenses at least 10-hours/day, 6-days/week. After dispensing, study visits were at 1-week, 1-month, 6-months and every 6-months until 6-years. At each visit, ocular measurements and subjective responses were recorded. Biomicroscopy used 0-4 grading scales; grade 0 represented no findings. Results: 144 children were enrolled: 69F:75M; mean age 10.1 years; mean cycloplegic spherical-equivalent refraction-2.11D; ethnicities included 34 East-Asian, 12 West-Asian, and 79 Caucasian. 92 completed the 6years. Only three subjects discontinued due to an ocular adverse event (AE). No contact lens related AEs were classified as serious. The incidence rate of infiltrative AEs was 0.61% (6.1/1000 wearing-years; 95%CI: 0.24%-1.57%). The most common biomicroscopy findings were limbal, bulbar and tarsal hyperaemia and tarsal roughness. 99% of all biomicroscopy findings were grade-1 or lower. After 6-years of lens wear, ocular health by biomicroscopy was similar to pre-lens wear. Conclusions: Across the 6-years, there were no contact lens related serious AEs and biomicroscopy showed no significant changes. Results suggest that children this age can successfully wear daily-disposable hydrogel contact lenses with minimal impact on ocular physiology.

Ocular and Nonocular Adverse Events during 3 Years of Soft Contact Lens Wear in Children

“…Bullimore 13 reported a corneal infiltrative event rate of 136 cases per 10,000 years of wear (95% CI, 50 to 300), based on aggregation of data from 3 prospective studies of children wearing soft contact lenses between the ages of 8 and 14 years. The 6-year MiSight follow-up study found a corneal infiltrative event rate of 61 cases per 10,000 patient-years (95% CI, 24 to 157) 8 . Our study found an incidence rate of 197 cases per 10,000 patient-years of wear (95% CI, 118 to 308).…”

“…A total of 2713 patient-years of wear elicited an annualized rate of noninfectious inflammatory adverse events of 660 cases per 10,000 years of wear (95% confidence interval [CI], 390 to 1050), and two cases of presumed or probable microbial keratitis resulted in a rate of 7.4 cases per 10,000 years of wear 6 . A subset of 144 of those children who were 8 to 12 years old at baseline and were prospectively examined for 6 years exhibited a corneal infiltrative event rate of 61 cases per 10,000 patient-years of wear, with no serious adverse events reported 8 …”

“…6 A subset of 144 of those children who were 8 to 12 years old at baseline and were prospectively examined for 6 years exhibited a corneal infiltrative event rate of 61 cases per 10,000 patient-years of wear, with no serious adverse events reported. 8 The Contact Lens Assessment in Youth Study Group conducted retrospective chart reviews and showed that the prevalence of corneal infiltrative events and that of contact lens discontinuation due to adverse events are lower in 8-to 17-year-old children than in 18to 25-year-old adults, 9,10 likely due to 18-to 25-year-old adults participating in more risky behaviors related to contact lens wear than the 8-to 17-year-old children. 11 A 2-year prospective study of 240 Chinese children between 7 and 14 years of age reported 55 adverse events, which yielded an adverse event incidence of 0.14 cases per 10,000 patient-years.…”

The Risks and Benefits of Myopia Control

“…In summary, the incidence of corneal infiltrative events and microbial keratitis in children 12 years and younger-in whom myopia control is likely to be initiated-is no higher than that observed in adults and may be lower. 85,86 The peak complication rate at 18-25 years suggests that behavioral and lifestyle factors may have a significant influence. 87 For 8-12-year-olds, parents are more likely to be involved in lens care.…”

Significances of Daily Disposable Contact Lenses During Covid-19

“…So due to these clinical scenarios, daily disposable contact lenses could be the best wearing options for contact lens users during pandemic of COVID-19. 11,13…”