Abstract
PurposeTo 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. MethodsChildren 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. Results144 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 6-years. 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. ConclusionsAcross 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.
Highlights
Fitting children with soft contact lenses for myopia control currently represents a very small percentage of all soft lens fits. [1] interest in this category is increasing worldwide, with many reports supporting soft lenses as a viable option for children and for myopia progression control [2,3,4,5,6,7,8,9,10].The average age of first contact lens fit can be expected to decrease as both parents and practitioners show increased interest in the benefits of myopia control lens designs
Initial contact lens fits for refractive correction were typically only undertaken on teenagers. [11,12] A recent fitting survey report indicates that the current median age for myopia control soft lens fitting is age 12, and that fitting children as young as age 8 is increasing in frequency [13]
A comparison of the reported findings at the Baseline Visit, prior to any contact lens wear, and at the Final Visit (6-year visit or exit visit for discontinued subjects) shows that there was no change in ocular phys iology signs over the contact lens wearing period. This clinical trial was designed to assess the efficacy of MiSight 1 day for controlling myopia progression and to assess the safety of soft con tact lens wear in a young neophyte cohort, fitted at age 8− 12 and fol lowed through early adolescence
Summary
Fitting children with soft contact lenses for myopia control currently represents a very small percentage of all soft lens fits. [1] interest in this category is increasing worldwide, with many reports supporting soft lenses as a viable option for children and for myopia progression control [2,3,4,5,6,7,8,9,10].The average age of first contact lens fit can be expected to decrease as both parents and practitioners show increased interest in the benefits of myopia control lens designs. [1] interest in this category is increasing worldwide, with many reports supporting soft lenses as a viable option for children and for myopia progression control [2,3,4,5,6,7,8,9,10]. [11,12] A recent fitting survey report indicates that the current median age for myopia control soft lens fitting is age 12, and that fitting children as young as age 8 is increasing in frequency [13]. With the increasing prevalence of myopia globally, in Asia [14], it is anticipated that fitting children as young as age 8 will become more commonplace.
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