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Not yet recruiting NCT07593469

Outcomes of Early Lacrimal Probing Versus Lacrimal Sac Massage in Infants With Congenital Nasolacrimal Duct Obstruction

No phase Interventional Lacrimal Duct Obstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: naslacrimal duct probing.
Who it may be relevant to
Registry conditions: Lacrimal Duct Obstruction. Basic parameters: 1 Day — 12 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This study aims to provide evidence on the optimal timing and efficacy of lacrimal probing in infants with congenital NLDO to minimize morbidity and healthcare costs .

Detailed description

Congenital nasolacrimal duct obstruction (CNLDO) manifests with symptoms such as excessive tearing, lash crusting, and mucopurulent secretions. A significant cohort study revealed that CNLDO affects one in nine newborns, highighting its public health significance 1.

Controversies per-sist regarding the most appropriate time and type of intervention for managing CNLDO2 .

Standard early management typically includes hydrostatic lacrimal sac massage combined with topical antibiotics. Many ophthalmologists believe that a majority of obstructions resolve spontaneously with massage; however, around 25% of children may require additional intervention such as probing 3.

Currently, there is no established consensus on the optimal timing for intervention in theses cases. Because of the possibility of spontaneous resolution, some authors recommend postponing probing until after one year of age . Conversely, other studies suggest that delaying probing beyond six months may increase the risk of inflammation and fibrosis, potentially lowering the success rates of later interventions 4.

Aim of the study This study aims to provide evidence on the optimal timing and efficacy of lacrimal probing in infants with congenital NLDO to minimize morbidity and healthcare costs .

Interventions

  • Procedure naslacrimal duct probing
    nasolacrimal duct probing

Primary outcome measures

  • epiphora stop evaluated by Munk scale and TEARS scale [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • patients with simple congenital nasolacrimal duct obstruction

Exclusion criteria

  • patients with complicated nasolacrimal duct obstruction

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07593469 · Soh-Med-26-4-9PD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗