Purpose: Previous studies in the United States have evaluated the benefits of soft contact lenses (CLs) in 8- to 12-year-old children and 13- to 17-year-old teens. This study was undertaken in Singapore and evaluated the safety, efficacy, and physiologic performance of daily disposable soft lenses in a population of children.
Methods: In this open-label, bilateral, 3-month dispensing study, 59 children (8-11 years) were fit with etafilcon A spherical or toric daily disposable lenses (1-DAY ACUVUE or 1-DAY ACUVUE for ASTIGMATISM, Vistakon, Jacksonville, FL). All subjects were neophytes requiring visual correction in both eyes. The refractive inclusion criteria were plano to -9.00 diopter (D) with astigmatism of < or =2.00DC in both eyes, or hyperopia of +0.50 to +6.00D with astigmatism of 0.75D or less. The subjects underwent follow-up evaluations, which included a questionnaire for parents and subjects, at 1 week, 1 month, and 3 months.
Results: Of the 59 subjects enrolled, 53 (90%) completed the study successfully. Six subjects were discontinued because of lens handling difficulties (four), unacceptable lens fit (one), and an adverse event (one). Adverse events were reported in three subjects, including the discontinuation, and in each case were due to a chalazion. Overall vision quality, overall comfort, and end-of-day comfort were graded significantly better at each of the follow-up visits compared with baseline with spectacles (P< or =0.0001). Both handling and reported symptoms improved during the course of the study. The questionnaire results indicated that most of both parents and subjects preferred CLs to spectacles across a wide variety of aspects including vision, comfort, handling, and appearance. Significantly, more limbal and bulbar hyperemia was noted at follow-up visits than at baseline (P=0.0001); however, no instances of hyperemia greater than grade 2 were noted at any visit. Significantly, more corneal staining was also noted at the 1- and 3-month follow-up visits than at baseline (21% at 3 months).
Conclusion: A high proportion of Singaporean children requiring vision correction are able to successfully wear daily disposable soft CLs over a 3-month period. Overall, slit lamp findings showed the prevalence of corneal staining in this study to be 21% at 3 months, which is lower than that previously reported in adults, but higher than that reported in the US Contact Lenses in Pediatrics study (6%).