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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07593469
Enrollment
50
Registered
2026-05-18
Start date
2026-06-01
Completion date
2026-10-01
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lacrimal Duct Obstruction

Brief summary

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

PROCEDUREnaslacrimal duct probing

nasolacrimal duct probing

Sponsors

Hany Mahmoud,MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

double blind

Intervention model description

randomized clinical trial

Eligibility

Sex/Gender
ALL
Age
1 Days to 12 Months
Healthy volunteers
No

Inclusion criteria

* patients with simple congenital nasolacrimal duct obstruction

Exclusion criteria

* patients with complicated nasolacrimal duct obstruction

Design outcomes

Primary

MeasureTime frameDescription
epiphora stop evaluated by Munk scale and TEARS scale3 monthsMunk 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.

Contacts

CONTACTHany Mahmoud
drhanymahmoud@gmail.com01024368111
STUDY_DIRECTORHany Mahmoud

Sohag University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026