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Lacrimal sac massage for congenital nasolacrimal duct obstruction: a multicentre randomised controlled trial
Mizuki Asano1,2, Masaki Takeuchi3, Tomoko Ohno1,2
1Department of Ophthalmology and Visual Science, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
Insights
Crigler massage did not significantly improve resolution rates for congenital nasolacrimal duct obstruction in infants aged 3-11 months. However, it showed promise in younger infants (3-5 months) who adhered strictly to the massage protocol.
Area of Science:
- Ophthalmology
- Pediatrics
Background:
- Congenital nasolacrimal duct obstruction (CNLDO) is a common condition in newborns, causing epiphora and discharge.
- Effective management strategies for CNLDO are crucial for infant well-being.
Purpose of the Study:
- To evaluate the efficacy of Crigler massage in resolving congenital nasolacrimal duct obstruction (CNLDO) in infants under one year of age.
- To compare the 1-month resolution rate between infants receiving Crigler massage and those not receiving it.
Main Methods:
- A multicentre randomized controlled trial involving 102 infants (3-11 months) with unilateral CNLDO.
- Infants were randomized into massage and non-massage groups (n=51 each).
- The massage group received daily Crigler massage for 1 month or until resolution.
Main Results:
- Overall resolution rates after 1 month did not differ significantly between the massage (31.4%) and non-massage (33.3%) groups.
- In protocol-compliant patients aged 3-5 months, the resolution rate was significantly higher in the massage group (68.8%) compared to the non-massage group (28.6%, p=0.022).
Conclusions:
- Crigler massage did not demonstrate a significant increase in resolution rates for CNLDO in infants aged 3-11 months after one month.
- Crigler massage may be effective for younger infants (3-5 months) with CNLDO, particularly when performed diligently and in accordance with the protocol.
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/).
