Standardized Lacrimal Sac Massage vs Probing for Congenital Nasolacrimal Duct Obstruction in Infants: A Noninferiority Randomized Trial.

Abstract

Congenital nasolacrimal duct obstruction (CNLDO) is a common condition in infants. While observation and surgical probing are commonly used in clinical practice, evidence to guide the choice between these approaches is lacking, and the efficacy of lacrimal sac massage remains controversial. To assess whether lacrimal sac massage is noninferior to lacrimal duct probing for treating CNLDO in infants. This noninferiority randomized clinical trial took place at an outpatient clinic in Guangzhou, China, from April to September 2025 and included 160 infants younger than 1 year with CNLDO, presenting with epiphora or discharge in 1 or both eyes since birth. Children with bilateral eye disease were only analyzed for the right eye. Patients were excluded if they had previously undergone surgery for CNLDO or had another systemic disease or ocular infection. Patients were randomly assigned to receive lacrimal duct probing in the consultation room (n = 80) or standardized, regular lacrimal sac massage performed by parents (n = 80). The primary outcome was the resolution rate at 3 months, defined as complete or substantial resolution of epiphora, alongside the complete resolution of purulent discharge. The prespecified noninferiority margin was -10 percentage points. The mean (SD) age of the participants was 6.2 (2.5) months, and 98 (61.3%) were male. Resolution occurred in 69 of 80 participants (86.2%) in the massage group compared with 67 of 80 (83.7%) in the probe group (difference, 2.5 percentage points; 95% CI, -8.78 to 13.76). No serious complications occurred. The mean (SD) symptom resolution time was 1.1 (0.5) weeks in the probe group and 3.8 (2.8) weeks in the massage group (difference, 2.7 weeks; 95% CI, 1.96 to 3.38; P < .001). For infants younger than 1 year with CNLDO, lacrimal sac massage for 3 months was noninferior to lacrimal duct probing in efficacy, with no serious complications in either group. These findings support lacrimal sac massage as an alternative to surgical probing for CNLDO in infants younger than 1 year similar to those enrolled in this trial. ClinicalTrials.gov Identifier: NCT06924723.