NCT07593469

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 .

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jun 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 8, 2026

Last Update Submit

May 13, 2026

Conditions

Lacrimal Duct Obstruction

Outcome Measures

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.

    3 months

Study Arms (2)

early probing

EXPERIMENTAL

patients with congenital nasolacrimal duct obstruction will undergo early probing

Procedure: naslacrimal duct probing

massage

NO INTERVENTION

patients with congenital nasolacrimal duct obstruction will undergo lacrimal massage

Interventions

naslacrimal duct probingPROCEDURE

nasolacrimal duct probing

early probing

Eligibility Criteria

Age1 Day - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • patients with simple congenital nasolacrimal duct obstruction

You may not qualify if:

  • patients with complicated nasolacrimal duct obstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lacrimal Duct Obstruction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Hany Mahmoud

    Sohag University

    STUDY DIRECTOR

Central Study Contacts

Hany Mahmoud

CONTACT

01024368111drhanymahmoud@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor of ophthalmology

Study Record Dates

First Submitted

May 8, 2026

First Posted

May 18, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

data are available upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
3 months
Access Criteria
all