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

NCT ID: NCT06924723

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

control subjects

Group Type: ACTIVE_COMPARATOR

tear duct probing

Intervention Type: 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.

experimental group

Group Type: EXPERIMENTAL

Lacrimal sac massage

Intervention Type: 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).

Interventions

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.

Intervention Type: 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 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).

Intervention Type: PROCEDURE

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;

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Xuanwei Liang

Role: CONTACT

liangxuanwei@163.com

+8613694220662

Other Identifiers

2025KYPJ036

Identifier Type: -

Identifier Source: org_study_id