Lacrimal sac massage for congenital nasolacrimal duct obstruction: a multicentre randomised controlled trial

Abstract

AimCongenital nasolacrimal duct obstruction (CNLDO) is the most common cause of epiphora and mucous discharge in the newborn. We conducted a multicentre randomised controlled trial to determine whether Crigler massage promotes the resolution of CNLDO in infants under 1 year of age.MethodsA total of 102 infants aged 3–11 months with unilateral CNLDO were enrolled in the study. Patients were randomly assigned to the massage and non-massage groups (n=51/group). As an allocation adjustment factor, the patients were divided into age groups of 3–5, 6–8 and 9–11 months. In the massage group, the guardian performed 10 strokes two times per day for each day until resolution or 1 month. The primary endpoint was a comparison of the 1-month resolution rate in the massage and non-massage groups.ResultsThis study included 49 male and 53 female patients with a mean age of 6.4±2.4 months. Overall, in this study, the resolution rate was not significantly different between the massage and non-massage groups (31.4% and 33.3%, respectively). However, the resolution rate was higher in the massage group in the 3–5 months age group among the protocol-compliant patients after excluding those with insufficient massage frequency (the massage group, 68.8% and the non-massage group, 28.6%, p=0.022).ConclusionsThere was no increase in the resolution rate after 1 month of lacrimal sac massage in patients 3–11 months old with unilateral CNLDO. However, in protocol-compliant younger age groups, Crigler massage may be effective.Trial registration numberUMIN Clinical Trial Registry (UMIN000032840;www.umin.ac.jp/).