Lacrimal Duct ObstructionNCT07593469
Outcomes of Early Lacrimal Probing Versus Lacrimal Sac Massage in Infants With Congenital Nasolacrimal Duct Obstruction
A study testing naslacrimal duct probing in people with Lacrimal Duct Obstruction, run by Hany Mahmoud,MD.
Trial 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 more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Lacrimal Duct Obstruction
- What is being tested?
- naslacrimal duct probing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients with simple congenital nasolacrimal duct obstruction
Who cannot join
- patients with complicated nasolacrimal duct obstruction
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this 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 .
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 .
- Conditions
- Lacrimal Duct Obstruction
- Being tested
- naslacrimal duct probing
- Medical subject headings
- Lacrimal Duct Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naslacrimal duct probingProcedure or surgery
nasolacrimal duct probing
| Study group | Role | What they receive |
|---|---|---|
| early probing | Experimental | patients with congenital nasolacrimal duct obstruction will undergo early probing Receives: Procedure: naslacrimal duct probing |
| massage | No intervention | patients with congenital nasolacrimal duct obstruction will undergo lacrimal massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lacrimal Duct ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hany Mahmoud,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hany Mahmoud,MD, Sohag University
- Investigators
- Hany Mahmoud, Study director, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593469
- Sponsor's protocol ID
- Soh-Med-26-4-9PD
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data are available upon request
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Early Lacrimal Probing Versus Lacrimal Sac Massage in Infants With Congenital Nasolacrimal Duct Obstruction
- ClinicalTrials.gov ID
- NCT07593469
- Acronym / sponsor ID
- Soh-Med-26-4-9PD
- Conditions
- Lacrimal Duct Obstruction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hany Mahmoud,MDUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| early probing | Experimental | Procedure: naslacrimal duct probingpatients with congenital nasolacrimal duct obstruction will undergo early probing |
| massage | No intervention | –patients with congenital nasolacrimal duct obstruction will undergo lacrimal massage |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- patients with simple congenital nasolacrimal duct obstruction
Key exclusion criteria (1 listed)
- patients with complicated nasolacrimal duct obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| naslacrimal duct probingnasolacrimal duct probing | Procedure or surgery | early probing |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Yes. data are available upon request
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Efficacy and Safety of Piclosept in the Complex Treatment of Neonatal Dacryocystitis
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Outcomes of Stentless Dacryocystorhinostomy in Primary Acquired Nasolacrimal Duct Obstruction.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hany Mahmoud study director
Sohag University
Questions about this trial
What is this clinical trial studying?
A study testing naslacrimal duct probing in people with Lacrimal Duct Obstruction, run by Hany Mahmoud,MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hany Mahmoud (01024368111, drhanymahmoud@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
epiphora stop evaluated by Munk scale and TEARS scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.