Abstract
Purpose :
Although effective in slowing progression of myopia in children, uptake of contact lens (CL) wear is slow as concerns exist around the safety of CL wear in children. To report on the incidence and to determine factors associated with adverse events with CL wear in children.
Methods :
Retrospective analysis of data from 3 trials involving 808 Chinese children with myopia (age 10.7±1.5; 7-14 yrs) fitted with CL. Duration of CL wear was 1.7±1.1 years. CL worn on a daily wear basis with fortnightly or daily replacement. Lens materials were Etafilcon A, Lotrafilcon B and Somofilcon A. Adverse events categorized as Serious, Significant, Non-significant and Other. Microbial keratitis(MK) was the only serious event. Significant events were corneal infiltrative events (CIE) (Contact Lens Peripheral Ulcer-CLPU and Infiltrative Keratitis-IK) or mechanical (Contact Lens Papillary Conjunctivitis-CLPC, Superior Epithelial Arcuate Lesion-SEAL, Corneal Erosion-CE). Non-significant events included asymptomatic infiltrates and asymptomatic infiltrative keratitis. Other events such as for e.g., stye were not analysed here. Incidence was the number of first events/100 patient eye years. Chi square and logistic regression were conducted to determine association with risk factors of age, gender, parental myopia and lens material (ages 8-14 only). Significance was p<0.05.
Results :
There were 2824.3 patient eye years in CL wear. A single event of presumed MK (0.04/ 100 patient eye years) resolved without sequelae. Of the significant events, there were 18 CIE (0.64/100 patient eye years) (5 CLPU; 8 IK) and 69 mechanical events (2.44/100 patient eye years; 43 CLPC, 11 SEAL & 17 CE). There were 58 non-significant events (2.05/100 patient eye years). Significant CIE were not associated with any risk factors. Mechanical events were associated with age, gender, and lens material. Logistic regression found males (2.3 times compared to females) and use of silicone hydrogel (lotrafilcon B and somofilcon A) associated with increased risk (43.2 and 10 times respectively).
Conclusions :
Overall, daily wear of CL in children was safe. Serious events were rare and significant CIE were few at less than 1/100 patient eye years. Mechanical events especially CLPC were more prevalent with lens material found to be a significant risk factor. Since these events were material dependant, alternative and newer lens materials provide an option to reduce the risk of such events.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.