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Randomized Controlled Trial
. 2013 Sep;90(9):961-9.
doi: 10.1097/OPX.0000000000000017.

Adverse events during 2 years of daily wear of silicone hydrogels in children

Padmaja Sankaridurg  1 , Xiang Chen, Thomas Naduvilath, Percy Lazon de la Jara, Zhi Lin, Li Li, Earl L Smith 3rd, Jian Ge, Brien A Holden
Affiliations
Randomized Controlled Trial

Adverse events during 2 years of daily wear of silicone hydrogels in children

Padmaja Sankaridurg et al. Optom Vis Sci. 2013 Sep.

Abstract

Purpose: Type and incidence of adverse events and rate of discontinuations for 2 years of daily wear with silicone hydrogel contact lenses in Chinese children with myopia.

Methods: Two hundred forty children aged 7 to 14 years were enrolled in a prospective randomized clinical trial from November 2008 to April 2009. Children with myopia of up to -3.50 diopters (D) spherical equivalent with astigmatism less than or equal to -0.75 D were randomized to one commercial and three experimental lens designs of Lotrafilcon B silicone hydrogel lenses (four groups) used bilaterally on a daily wear, monthly replacement schedule. The main outcome measures were incidence per 100 patient-years (incidence, in percentage) of adverse events and rate of discontinuations.

Results: There were no events of microbial keratitis. Fifty-five adverse events (incidence, 14.2%) were seen. There were also 12 recurrent events. The type and incidence percentage were contact lens papillary conjunctivitis (16 events, 4.1%), superior epithelial arcuate lesions (SEALs, six events, 1.5%), corneal erosions (eight events, 2.1%), infiltrative keratitis (five events, 1.3%), asymptomatic infiltrative keratitis (seven events, 1.8%), and asymptomatic infiltrates (13 events, 3.42%). There were differences in the incidence of SEALs between groups (p = 0.023), with the incidence of SEALs being greater with one of the experimental designs. No event resulted in any vision loss. Seventy participants (29.2%) discontinued, with one-third (26 participants, 10.8%) occurring in the first month of lens wear. Discomfort and non-lens-related reasons such as safety concern and disinterest were frequently cited reasons for discontinuations.

Conclusions: Adverse events with daily wear of silicone hydrogels in children were mainly mechanical in nature, and significant infiltrative events were few. The large number of dropouts in the early days of lens wear and their reasons for discontinuation suggest that adaptation and patient motivation are critical for survival in lens wear.

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Figures

FIGURE 1
FIGURE 1
Incidence of significant adverse events.
FIGURE 2
FIGURE 2
Incidence of nonsignificant adverse events.
FIGURE 3
FIGURE 3
Time of occurrence of events.
FIGURE 4
FIGURE 4
Cumulative discontinuation rate (%).
See this image and copyright information in PMC

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