5 years of daily disposable contact lens wear in children
Jill Woods MSc MCOptom FAAO FBCLA
Debbie Jones BSc FCOptom FAAO
Lyndon Jones PhD DSc FCOptom FAAO FBCLA
Graeme Young PhD FCOptom FAAO
Chris Hunt MSc
Paul Chamberlain BSc MCOptom
John McNally OD FAAO
The MiSight® 1 day Clinical Study Group
Purpose: To report on the ocular health data and safety profile of soft hydrogel daily disposable contact lenses when fitted to children and worn during the first five years of an ongoing clinical trial of a dual-focus contact lens designed to control myopia progression.
Method: Children aged 8-12 years old, who were new to contact lens wear, were fitted in a randomised masked study to wear omafilcon A daily disposable contact lenses in either a spherical (Proclear 1 day, CVI) or a myopia control design (MiSight 1 day, CVI) for 3-years. The two lens designs were identical in geometry except for the front surface optical zone, which provided the myopia control design. During years four and five, all children wore the myopia control design lens. Follow-up visits were scheduled after 1-week, 1-month, 6-months and thereafter every 6-months. At each visit, visual performance and biomicroscopy were assessed and subjective feedback was collected.
Results: 144 children were enrolled in the study: mean age 10.1±1.4 years; mean cycloplegic spherical equivalent refraction of -2.11D (-0.77 to -4.00).; 69F/75M; multiple ethnicities including 34 East Asian, 12 West Indian, 79 Caucasian. 98 completed this 5-year period. The average wearing schedule was 12.4 hours a day, 6.5 days a week. Over these 5-years, there were no contact lens related, serious adverse events and the contact lens related ocular adverse event rate was 3.4 per 100 lens wearing years (95%CI: 2.2 to 5.2). The majority of biomicroscopy findings across all visits were grade 0 (equivalent to no findings) and at the end of 5-years the grade distribution was similar to baseline levels, before lens wear commenced. There was no evidence of hypoxic changes from biomicroscopy
Conclusions: These results support that children in this age cohort successfully wore hydrogel, daily disposable contact lenses over a 5-year period with minimal impact on ocular physiology.
1st Author Biography: Jill is Head of Clinical Research at the Centre for Ocular Research & Education (CORE), University of Waterloo, Canada, which she joined in 2005. She oversees clinical research trials from concept to final report, and serves on CORE’s management team. Jill’s work mainly involves the fields of contact lenses, with particular interest in presbyopia and comfort, and controlling myopia progression. Jill completed her Optometry degree in London, UK and has experience in her own private practice, low-vision hospital work, clinical teaching and continuing education. She attained her PostGradCert in Bus Admin in 2004 and her MSc in 2019.
*Data correct at the time of submission to BCLA by NCC.