Effect of Standardized Lacrimal Sac Massage Compared With Probing for Congenital Lacrimal Duct Obstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: tear duct probing, Lacrimal sac massage.
- Who it may be relevant to
- Registry conditions: Nasolacrimal Duct Obstruction. Basic parameters: 3 months — 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Standardized Lacrimal Sac Massage Compared With Probing for Congenital Lacrimal Duct Obstruction: a Non-inferiority, Randomized Clinical Trial
Overview
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.
Interventions
- Procedure tear duct probing
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. - Procedure Lacrimal sac massage
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
Primary outcome measures
- Treatment success of congenital tear duct obstruction at 3 months of treatment [Time frame: At 3 months of starting treatment]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06924723 · 2025KYPJ036