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Abstract
Aim Congenital 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.
Methods A 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.
Results This 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).
Conclusions There 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 number UMIN Clinical Trial Registry (UMIN000032840; www.umin.ac.jp/).
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Data availability statement
Data are available upon reasonable request. The trial protocol and the data supporting the findings of this study are available from the corresponding author upon reasonable request.
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Data availability statement
Data are available upon reasonable request. The trial protocol and the data supporting the findings of this study are available from the corresponding author upon reasonable request.
Footnotes
MA and MT contributed equally.
Presented at This work was presented as an oral presentation at the 11th Annual Meeting of the Japanese Society of Lacrimal Passage and Tear Dynamics in Osaka, Japan, on 9 July 2023.
Contributors MA, MT, TO, NMi and NMa formulated and designed the methodology for the analysis. MA, MT, TO and NMa conducted the primary data collection process. MA, MT, JN and NMa contributed to the manuscript by providing specialised analysis tools. MA, MT, JN and NMa performed the statistical analysis and interpretation of the data. MA, MT, TO, NMi and NMa contributed equally to drafting and revising the manuscript. MT is guarantor.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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