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NCT Number: NCT07593469

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

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 .

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Key information

Age range

1 day–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with simple congenital nasolacrimal duct obstruction

Exclusion criteria

  • patients with complicated nasolacrimal duct obstruction

Treatment and study plan

naslacrimal duct probing

Procedure

nasolacrimal duct probing

Primary outcomes

  1. epiphora stop evaluated by Munk scale and TEARS scale

    Time frame: 3 months

    Munk Scale, which ranges from 0 (no tearing) to 5 (constant tearing) based on daily wiping frequency.

    TEARS Scale, which measures four subscales: Times of wiping, Effects (clinical), Activity limitations, and Reflex tearing.

Study contacts

Contact information is provided by the study sponsor or research team.

Hany Mahmoud

CONTACT

[email protected]

01024368111

Sponsors and collaborators

Lead sponsor

Hany Mahmoud,MD

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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