Nasolacrimal Duct ObstructionNCT06924723
Effect of Standardized Lacrimal Sac Massage Compared With Probing for Congenital Lacrimal Duct Obstruction
A study testing tear duct probing and Lacrimal sac massage in people with Nasolacrimal Duct Obstruction, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
Trial summary
Congenital nasolacrimal duct obstruction (CNLDO) is a common ophthalmic condition in children, presenting with tearing and pus overflow, with a prevalence of 5%-20% within 1 year of age. Although most cases resolve spontaneously within 1 year of age, some children require treatment. Read more about this study
- Who is it for?
- Ages 3 months to 1 year
- Conditions the study is for
- Nasolacrimal Duct Obstruction
- What is being tested?
- tear duct probing and Lacrimal sac massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Jan 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 3 months to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 3 months to 1 year;
- Presence of at least one symptom of CNLDO (tear spillage, mucous discharge) in one or both eyes;
- No surgical treatment for NLD (probing, balloon dilation, tube placement, DCR, etc.);
- Can cooperate with the examination and subsequent follow-up;
- Guardians agreed to be enrolled in the study and signed an informed consent form.
Who cannot join
- Combination of presenting infections of the conjunctiva and cornea;
- Combination of other serious ocular surface and intraocular disorders that may affect the therapeutic effect;
- Congenital malformation syndromes, developmental delays, facial anomalies, facial deformities; history of surgery or injury to the lacrimal duct, history of punctal occlusion, history of lacrimal fistula, history of congenital bulging of the lacrimal sac, history of acute dacryocystitis, history of severe blepharitis, and perinatal abnormalities such as preterm labor, low birth weight, and so on;
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
Official title: Effect of Standardized Lacrimal Sac Massage Compared With Probing for Congenital Lacrimal Duct Obstruction: a Non-inferiority, Randomized Clinical Trial
Congenital nasolacrimal duct obstruction (CNLDO) is a common ophthalmic condition in children, presenting with tearing and pus overflow, with a prevalence of 5%-20% within 1 year of age. Although most cases resolve spontaneously within 1 year of age, some children require treatment. Lacrimal sac massage is a non-invasive, easy and cost-effective conservative treatment that helps to unblock the obstruction by increasing the pressure in the tear duct. Studies have shown that massage has a 93% cure rate in children under 8 months of age. In contrast, tear duct probing is effective but invasive and risky. In recent years, with the development of minimally invasive techniques, lacrimal sac massage has received renewed attention, and studies have shown its efficacy to be comparable to probing. However, there are problems of non-standardized massage timing and techniques in clinical practice, which affects the therapeutic efficacy. This study aims to assess whether the efficacy of standardized dacryocystic massage is not inferior to that of dacryocystorhinostomy through a randomized controlled trial, providing a reference for the treatment of CNLDO.
- Conditions
- Nasolacrimal Duct Obstruction
- Being tested
- tear duct probing, Lacrimal sac massage
- 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.
tear duct probingProcedure or surgery
In-office tear duct exploratory surgery was performed on the study participants, and the children were closely monitored for healing after the procedure.
The children were closely monitored for healing afterward, and the patients were also examined at 1 week, 1 month, and 2 months after the start of treatment.
Lacrimal sac massageProcedure or surgery
At the time of the visit, the patient's parents (one of them) were given Standardized tear duct massage (Crigler massage)Teaching and hands-on practice were performed, with the researcher confirming the standardization of movements.Subsequent massages were performed by the family member who received the training, and the child's family swiped the card to access the program.completed by the family member of the child, who scanned the code to enter the small program punch card group, according to the standardized process of massage (the frequency of massage was not less than 3 times/day, each time no less than 4 eight beats)And complete the punch card on time (each punch card interval should be greater than 2 hours).(each clock interval should be more than 2 hours).
| Study group | Role | What they receive |
|---|---|---|
| control subjects | Active comparator | Not described Receives: Procedure: tear duct probing |
| experimental group | Experimental | Not described Receives: Procedure: Lacrimal sac massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success of congenital tear duct obstruction at 3 months of treatment
Cure rate of congenital lacrimal obstruction at 3 months of treatment: patients with symptoms of lacrimal obstruction (tearing, pus overflow) disappeared are considered cured; lacrimal irrigation patency rate at 3 months of treatment (all lacrimal irrigation fluid goes into the throat, and no reflux is considered to be patency)
Measured: At 3 months of starting treatment
Secondary outcomes (3)
Lacrimal flushing patency at 3 months after the start of treatment
Whether the tear duct flushing is smooth
Measured: at 3 months after the start of treatment
Incidence of complications during treatment
Counting adverse events over the course of 3 months of treatment
Measured: at 3 months after the start of treatment
Recurrence of symptoms within 1 month of cure
Observe whether the patient has recurrence of tearing and pus overflow symptoms within 1 month after cure
Measured: 1 month after cure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasolacrimal Duct ObstructionStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924723
- Sponsor's protocol ID
- 2025KYPJ036
- Status last verified
- Mar 2025
- First submitted
- 5 Apr 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zheng X, Yu X, Wu G, Zhang J, Wang K, Jin L, Huang S, Chen R, Yu H, Huang W, Li Z, Liang X. Standardized Lacrimal Sac Massage vs Probing for Congenital Nasolacrimal Duct Obstruction in Infants: A Noninferiority Randomized Trial. JAMA Ophthalmol. 2026 Aug 13:e263169. doi: 10.1001/jamaophthalmol.2026.3169. Online ahead of print.
PubMed 42593819
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Standardized Lacrimal Sac Massage Compared With Probing for Congenital Lacrimal Duct Obstruction: a Non-inferiority, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06924723
- Acronym / sponsor ID
- 2025KYPJ036
- Conditions
- Nasolacrimal Duct Obstruction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 11 Apr 2025 (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.
Congenital nasolacrimal duct obstruction (CNLDO) is a common ophthalmic condition in children, presenting with tearing and pus overflow, with a prevalence of 5%-20% within 1 year of age. Although most cases resolve spontaneously within 1 year of age, some children require treatment. Lacrimal sac massage is a non-invasive, easy and cost-effective conservative treatment that helps to unblock the obstruction by increasing the pressure in the tear duct. Studies have shown that massage has a 93% cure rate in children under 8 months of age. In contrast, tear duct probing is effective but invasive and risky. In recent years, with the development of minimally invasive techniques, lacrimal sac massage has received renewed attention, and studies have shown its efficacy to be comparable to probing. However, there are problems of non-standardized massage timing and techniques in clinical practice, which affects the therapeutic efficacy. This study aims to assess whether the efficacy of standardized dacryocystic massage is not inferior to that of dacryocystorhinostomy through a randomized controlled trial, providing a reference for the treatment of CNLDO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control subjects | Active comparator | Procedure: tear duct probing |
| experimental group | Experimental | Procedure: Lacrimal sac massage |
Who may qualify
- Ages
- 3 months to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age from 3 months to 1 year;
- Presence of at least one symptom of CNLDO (tear spillage, mucous discharge) in one or both eyes;
- No surgical treatment for NLD (probing, balloon dilation, tube placement, DCR, etc.);
- Can cooperate with the examination and subsequent follow-up;
- Guardians agreed to be enrolled in the study and signed an informed consent form.
Key exclusion criteria (3 listed)
- Combination of presenting infections of the conjunctiva and cornea;
- Combination of other serious ocular surface and intraocular disorders that may affect the therapeutic effect;
- Congenital malformation syndromes, developmental delays, facial anomalies, facial deformities; history of surgery or injury to the lacrimal duct, history of punctal occlusion, history of lacrimal fistula, history of congenital bulging of the lacrimal sac, history of acute dacryocystitis, history of severe blepharitis, and perinatal abnormalities such as preterm labor, low birth weight, and so on;
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 |
|---|---|---|
| tear duct probingIn-office tear duct exploratory surgery was performed on the study participants, and the children were closely monitored for healing after the procedure. The children were closely monitored for healing afterward, and the patients were also examined at 1 week, 1 month, and 2 months after the start of treatment. | Procedure or surgery | control subjects |
| Lacrimal sac massageAt the time of the visit, the patient's parents (one of them) were given Standardized tear duct massage (Crigler massage)Teaching and hands-on practice were performed, with the researcher confirming the standardization of movements.Subsequent massages were performed by the family member who received the training, and the child's family swiped the card to access the program.completed by the family member of the child, who scanned the code to enter the small program punch card group, according to the standardized process of massage (the frequency of massage was not less than 3 times/day, each time no less than 4 eight beats)And complete the punch card on time (each punch card interval should be greater than 2 hours).(each clock interval should be more than 2 hours). | Procedure or surgery | experimental group |
Primary outcome
Treatment success of congenital tear duct obstruction at 3 months of treatment
Time frame: At 3 months of starting treatment
Cure rate of congenital lacrimal obstruction at 3 months of treatment: patients with symptoms of lacrimal obstruction (tearing, pus overflow) disappeared are considered cured; lacrimal irrigation patency rate at 3 months of treatment (all lacrimal irrigation fluid goes into the throat, and no reflux is considered to be patency)
3 secondary outcomes
Lacrimal flushing patency at 3 months after the start of treatment
Time frame: at 3 months after the start of treatment
Incidence of complications during treatment
Time frame: at 3 months after the start of treatment
Recurrence of symptoms within 1 month of cure
Time frame: 1 month after cure
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 11 Apr 2025.
- Derived from this study: PubMed 42593819Zheng X, Yu X, Wu G, Zhang J, Wang K, Jin L, Huang S, Chen R, Yu H, Huang W, Li Z, Liang X. Standardized Lacrimal Sac Massage vs Probing for Congenital Nasolacrimal Duct Obstruction in Infants: A Noninferiority Randomized Trial. JAMA Ophthalmol. 2026 Aug 13:e263169. doi: 10.1001/jamaophthalmol.2026.3169. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Nasolacrimal Duct Obstruction
RecruitingPhase 3
Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Treated With Radioactive Iodine for Thyroid Cancer
Nasolacrimal Duct Obstruction, Thyroid Cancer
Active, not recruitingPhase 4
Efficacy and Safety of Piclosept in the Complex Treatment of Neonatal Dacryocystitis
Neonatal Dacryocystitis, Congenital Nasolacrimal Duct Obstruction
Not yet recruiting
Outcomes of Stentless Dacryocystorhinostomy in Primary Acquired Nasolacrimal Duct Obstruction.
Nasolacrimal Duct Obstruction, Epiphora
Not yet recruiting
Outcomes of Early Lacrimal Probing Versus Lacrimal Sac Massage in Infants With Congenital Nasolacrimal Duct Obstruction
Lacrimal Duct Obstruction
Recruiting
Comparative Outcomes of Four Versus Two Balloon Inflation Points in Dacryoplasty for Primary Acquired Nasolacrimal Duct Obstruction
Primary Acquired Nasolacrimal Duct Obstruction
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.
Questions about this trial
What is this clinical trial studying?
A study testing tear duct probing and Lacrimal sac massage in people with Nasolacrimal Duct Obstruction, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
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 5 inclusion and 3 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 11 Apr 2025. 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 Xuanwei Liang (+8613694220662, liangxuanwei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success of congenital tear duct obstruction at 3 months of treatment (time frame: At 3 months of starting treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06924723, which also lists 1 linked publication.
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 11 Apr 2025.