Monthly replacement soft contact lens safety in children across 3 years in the BLINK study

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

Authors: Amber Gaume Giannoni (1), Matt Robich (2), David Bernsten (1), Lisa Jones-Jordan (2), Donald Mutti (2), Jill Myers (2), Kimberly Shaw (2), Maria Walker (1, 2), Jeffrey Walline (2)

1. University of Houston College of Optometry, Houston, Texas
2. The Ohio State University College of Optometry, Columbus, Ohio

Date: June 2022

Reference: Gaume Giannoni A, Robich M, Berntsen DA, Jones-Jordan LA, Mutti DO, Myers J, Shaw K, Walker MK, Walline JJ; BLINK Study Group. Ocular and Nonocular Adverse Events during 3 Years of Soft Contact Lens Wear in Children. Optom Vis Sci. 2022 Jun 1;99(6):505-512.   (Link to abstract)

This study reported the frequency and type of ocular and non-ocular adverse events related to soft contact lens wear in children. The participants of the BLINK (Bifocal Lenses in NearSighted Kids) study for myopia control with center-distance multifocal soft contact lenses were 294 children between the ages of 7 and 11 wore frequent replacement (monthly) soft contact lenses for 3 years. Adverse events were defined on clinical signs, symptoms and/or parental report, and categorized as mild, moderate or severe. Whether they were related to contact lens wear, or not, was also analyzed.

Results:

• Children wore contact lenses an average of 70.3± 26.5 hours per week
• 74.8% (n=220) experienced at least 1 adverse event
• Of the total 432 adverse events, approximately 75% were ocular and 25% were non-ocular. Three-quarters of ocular adverse events were mild (not interrupting contact lens wear or requiring prescription) and one-quarter were moderate ("interferes with daily activities or are treated with prescription"). None were severe. The three most common ocular adverse events were solution induced corneal staining (28%), ocular allergies (14%) and hordeola/chalazia (7%). 
• Non-ocular adverse events included general health issues, 6% of which were serious (eg. broken bones, meningitis) and almost all unrelated or unknown to be related contact lens wear.
• The incidence of corneal infiltrates was 185 cases per 10,000 patient years of wear
• The incidence of moderate ocular adverse events that were definitely or probably related to contact lens wear was 405 cases per 10,000 patient years of wear 
• Importantly, none of the adverse events were serious, severe or caused permanent contact lens discontinuation.

The results from this study suggest that children as young as 7 years of age at fitting can successfully wear frequent monthly replacement silicone hydrogel contact lenses for multiple consecutive years. The adverse events encountered rarely required meaningful treatment and never led to a permanent discontinuation of contact lens wear or loss of best-corrected vision.

This should provide eye care practitioners with confidence regarding the long term safety of monthly disposable soft contact lenses in children.

Due to the nature of the study, it is not possible to examine risk factors for adverse events that were observed. It is of interest to identify patient factors (such as age and sex) that increase the risk of adverse events, so that practitioners can increase surveillance of these groups.

We still need to learn about the safety profile of daily disposable contact lenses in younger children (5-7 years) as there is increasing popularity of myopia control contact lenses in this age group.

Read more about the safety of daily disposable contact lenses in children over a 6-year period in this Myopia Profile Science Summary.

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

Authors: Amber Gaume Giannoni, Matt Robich, David Bernsten, Lisa Jones-Jordan, Donald Mutti, Jill Myers, Kimberly Shaw, Maria Walker, Jeffrey Walline

Purpose: Children are being fitted at younger ages with soft contact lenses for myopia control. This 3-year investigation of adverse events related to contact lens wear in 7- to 11-year-old participants helps optometrists understand what to expect when fitting children with soft contact lenses.

The purpose of this article is to report the frequency and type of ocular and nonocular adverse events related to soft contact lens wear in children.

Methods: Seven- to 11-year-old children wore soft contact lenses for 3 years. Adverse events were defined by a slit-lamp examination finding of grade 3 or worse; parental report of a clinically meaningful change (determined by the examiner) in eyes, vision, or health; or a clinically meaningful response (determined by examiner) to a symptom checklist. Adverse events were categorized and reported by examiners and finalized by the Executive Committee. The presence or absence of an infiltrate and a list of diagnoses was determined at the conclusion of the study.

Results: The 294 participants wore their contact lenses 73.0 ± 26.5 hours per week, and 220 (74.8%) encountered at least 1 adverse event. Of the 432 adverse events, 75.2% were ocular, and 24.8% were nonocular. Contact lens wear was probably or definitely related to 60.6% of the ocular and 2.8% of the nonocular adverse events. None of the ocular adverse events were serious or severe or caused permanent contact lens discontinuation. The corneal infiltrate incidence was 185 cases per 10,000 patient-years of wear (95% confidence interval, 110 to 294). The incidence of moderate ocular adverse events that were definitely or probably related to contact lens wear was 405 cases per 10,000 patient-years of wear (95% confidence interval, 286 to 557).

Conclusion: The adverse events experienced by 7- to 11-year-old myopic children rarely required meaningful treatment and never led to permanent discontinuation of contact lens wear or loss of best-corrected vision.

Abstract link is here