Effect of Standardized Lacrimal Sac Massage Compared With Probing for Congenital Lacrimal Duct Obstruction

NCT06924723 | Not Yet Recruiting

• 1 other identifier: 2025KYPJ036
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nasolacrimal Duct Obstruction

Outcome Measures

Primary Outcomes (1)

• 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)

  At 3 months of starting treatment

Secondary Outcomes (3)

• Lacrimal flushing patency at 3 months after the start of treatment

  at 3 months after the start of treatment

• Incidence of complications during treatment

  at 3 months after the start of treatment

• Recurrence of symptoms within 1 month of cure

  1 month after cure

Study Arms (2)

control subjects

ACTIVE COMPARATOR

Procedure: tear duct probing

experimental group

EXPERIMENTAL

Procedure: Lacrimal sac massage

Interventions

tear duct probing PROCEDURE

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.

control subjects

Lacrimal sac massage PROCEDURE

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).

experimental group

Eligibility Criteria

• Age: 3 Months - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

MeSH Terms

Conditions

Lacrimal Duct Obstruction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Xuanwei Liang

CONTACT

+8613694220662; liangxuanwei@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2025
• First Posted: April 11, 2025
• Study Start: May 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: January 1, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share