ClinicalTrials.gg
Not yet recruitingNCT07593469Updated May 18, 2026

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

An interventional study of naslacrimal duct probing in Lacrimal Duct Obstruction, sponsored by Hany Mahmoud,MD. Not yet recruiting. Open to participants aged 1 Day to 12 Months. Per ClinicalTrials.gov, last updated 2026-05-18.

Sponsored by Hany Mahmoud,MD · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
1 Day to 12 Months
Sex
All
01

Study 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 .

Read the 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 .

02

Conditions studied

  • Lacrimal Duct Obstruction
03

In context

Lacrimal Duct Obstruction

41 studies on the registry are indexed under Lacrimal Duct Obstruction; 8 are open to participants now.

This study's planned enrollment of 50 is below the median of 75 across 30 interventional studies indexed under Lacrimal Duct Obstruction.

Browse Lacrimal Duct Obstruction studies →

Lead sponsor

This is the only study on the registry with Hany Mahmoud,MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 12 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with simple congenital nasolacrimal duct obstruction

Exclusion criteria

Exclusion Criteria:

  • patients with complicated nasolacrimal duct obstruction
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    early probing

    patients with congenital nasolacrimal duct obstruction will undergo early probing

    Procedure: naslacrimal duct probing

  • No intervention
    massage

    patients with congenital nasolacrimal duct obstruction will undergo lacrimal massage

Interventions

  • Procedurenaslacrimal duct probing

    nasolacrimal duct probing

06

What researchers measure

Primary outcomes

  1. epiphora stop evaluated by Munk scale and TEARS scale

    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.

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — data are available upon request

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: 3 months

Access criteria: all

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07593469
Lead sponsor
Hany Mahmoud,MD
Responsible party
Hany Mahmoud,MD (professor of ophthalmology, Sohag University) — Sponsor-investigator
First posted
May 18, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Sep 1, 2026 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
May 18, 2026

Study contacts

Hany Mahmoud
Contact
drhanymahmoud@gmail.com
01024368111
Hany Mahmoud
study director · Sohag University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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