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Clinical Trials/NCT07593469
NCT07593469Not yet recruitingNot Applicable

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

Hany Mahmoud,MD0 sites50 target enrollmentStarted: June 1, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
50

Study Overview

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 .

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

double blind

Eligibility Criteria

Ages
1 Day to 12 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • patients with simple congenital nasolacrimal duct obstruction

Exclusion Criteria

  • patients with complicated nasolacrimal duct obstruction

Investigators

Sponsor
Hany Mahmoud,MD
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Hany Mahmoud,MD

professor of ophthalmology

Sohag University

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