Clinical trial NCT06924723: Effect of Standardized Lacrimal Sac Massage Compared With Probing for Congenital Lacrimal Duct Obstruction
Official title: Effect of Standardized Lacrimal Sac Massage Compared With Probing for Congenital Lacrimal Duct Obstruction: a Non-inferiority, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nasolacrimal Duct Obstruction
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 160
Sex: ALL
Minimum age (years): 3
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Age from 3 months to 1 year;
2. Presence of at least one symptom of CNLDO (tear spillage, mucous discharge) in one or both eyes;
3. No surgical treatment for NLD (probing, balloon dilation, tube placement, DCR, etc.);
4. Can cooperate with the examination and subsequent follow-up;
5. Guardians agreed to be enrolled in the study and signed an informed consent form.

Exclusion Criteria:

1. Combination of presenting infections of the conjunctiva and cornea;
2. Combination of other serious ocular surface and intraocular disorders that may affect the therapeutic effect;
3. 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;

Primary outcomes:
measure: Treatment success of congenital tear duct obstruction at 3 months of treatment
timeFrame: At 3 months of starting treatment
Secondary outcomes:
measure: Lacrimal flushing patency at 3 months after the start of treatment
timeFrame: at 3 months after the start of treatment
measure: Incidence of complications during treatment
timeFrame: at 3 months after the start of treatment
measure: Recurrence of symptoms within 1 month of cure
timeFrame: 1 month after cure
Other outcomes:
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