地夸磷索钠滴眼液对配戴角膜塑形镜的干眼患儿的疗效及安全性OA

•AIM:To evaluate the efficacy and safety of 3%diquafosol sodium eye drops in children wearing orthokeratology lenses and with dry eye disease(DED)or at risk of DED. •METHODS:Randomized controlled trials.Children with DED or at risk of DED were randomly assigned in a 1∶1 ratio to receive either 3%diquafosol sodium eye drops 6 times daily or a blank control at Chongqing Aier Children's Eye Hospital from November 2023 to November 2024.The primary endpoint was the change in the Dry Eye Questionnaire-5(DEQ-5)score from baseline at 12 wk.Secondary assessments included non-invasive breakup time(NIBUT),tear meniscus height,Schirmer's test,corneal fluorescein staining score,and axial length. •RESULTS:A total of 80 participants(80 eyes)were enrolled(40 in each group),the average age of the participants was 11.11±1.88 years,with 43 females(54%)and 37 males(46%),and all completed the trial.After 12 wk,the DEQ-5 scores for the diquafosol sodium group and the blank control group were 1.88±2.02 and 2.88±2.79,respectively(P=0.079).The diquafosol sodium group demonstrated a significant improvement in DEQ-5 dryness symptom scores(-0.33±0.66 vs.0.05±0.81,P=0.023)and NIBUT(6.18±3.73 vs.-1.09±4.40 s,P<0.001)at 12 wk.Additionally,the diquafosol sodium group showed no axial length elongation,in contrast to the blank control group,which exhibited elongation(0.00±0.08 vs.0.05±0.10 mm,P=0.013).No other significant differences were found in the secondary endpoints.No adverse events occurred during the trial. • CONCLUSION:Although no statistically significant improvements were noted in the overall DEQ-5 scores,the 3%diquafosol sodium eye drops significantly improved dryness symptoms and NIBUT when compared to the blank control group.