June 2020
Volume 61, Issue 7
ARVO Annual Meeting Abstract  |   June 2020
Estimate of Adverse Event Rates in a Retrospective Cohort Study of Safety of Pediatric Soft Contact Lens Wear: the ReCSS Study
Author Affiliations & Notes
  • Robin Chalmers
    Clinical Trial Consultant, Atlanta, Georgia, United States
  • John McNally
    CooperVision, Pleasanton, California, United States
  • Paul Chamberlain
    CooperVision, Pleasanton, California, United States
  • Lisa Keay
    School of Optometry, University of New South Wales, Sydney, New South Wales, Australia
  • Footnotes
    Commercial Relationships   Robin Chalmers, Alcon Research, Ltd (C), CooperVision (C), Johnson & Johnson Vision (C), Vision Service Plan (C); John McNally, CooperVision Corporation (E); Paul Chamberlain, CooperVision (E); Lisa Keay, CooperVision (C)
  • Footnotes
    Support  Sponsored by CooperVision Corp.
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 5215. doi:
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      Robin Chalmers, John McNally, Paul Chamberlain, Lisa Keay; Estimate of Adverse Event Rates in a Retrospective Cohort Study of Safety of Pediatric Soft Contact Lens Wear: the ReCSS Study. Invest. Ophthalmol. Vis. Sci. 2020;61(7):5215.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose : To measure the adverse event (AE) rate among children wearing soft contact lenses (SCLs) who were initially fit with lenses between the ages of 8-12 years (inclusive). AEs included microbial keratitis (MK), contact lens peripheral ulcers (CLPU), contact lens acute red eye (CLARE), infiltrative keratitis (IK), contact lens papillary conjunctivitis (CLPC) and other more minor AEs.

Methods : The IRB-approved study retrospectively reviewed clinical charts from 782 children in 7 geographically and ethnically diverse private US eye care clinics as well as data from 181 subjects in two randomized clinical trials. All children were first fit while 8-12 years old in various SCL brands, prescriptions and wearing schedules. Eligible charts included data up until 17 years of age. Total data included 2,713 years-of-wear across 4,611 visits in 963 children. Clinical records from visits with potential AEs were scanned and the entire charts reviewed to a consensus diagnosis by an independent Expert Adjudication Panel.

Results : The observed cohort was 46% male, median time of first SCL fit was during their 11th year and the average observed wear was 2.8±1.5 years per child. Sixty percent were first fit with daily disposable lenses. There were 122 potential ocular AEs from 118 of the 963 wearers which were reviewed and adjudicated by the Expert Adjudication Panel. The annualized rate of inflammatory AEs (CLPU, CLARE and IK) was 0.66%/year (95% CI 0.39–1.05) and the annualized rate of CLPC was 0.48%/year (95% CI 0.25-0.82). Two (2) presumed or probable MK cases were adjudicated yielding an estimated incidence rate of 7.4/10,000 years of wear (95% CI 1.8–29.6). The MK events were in boys of 13 and 14 years of age, one who reported occasionally non-compliant behavior of sleeping in lenses. Only one case resulted in a scar with no loss of visual acuity.

Conclusions : The ReCSS study was of sufficient size to estimate the MK rate in SCL wearers aged 8-17 years at 7.4/10,000 years (95% CI 1.8–29.6), comparable to established rates in adults wearing SCLs daily. The rate of other inflammatory AEs was similarly low. This study sheds additional light on the safety profile of SCLs when used by children and will help clinicians counsel families as they consider myopia control.

This is a 2020 ARVO Annual Meeting abstract.


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