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

Not Applicable

Not yet recruiting

• Conditions: Nasolacrimal Duct Obstruction

• Registration Number: NCT06924723
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-04-05
• Study First Submitted QC: 2025-04-05
• Last Update Submitted: 2025-04-05
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11
• Study Start: 2025-05-01
• Primary Completion: 2025-10-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Treatment success of congenital tear duct obstruction at 3 months of treatment	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)

Secondary Outcome Measures

Name	Time	Method
Incidence of complications during treatment	at 3 months after the start of treatment	Counting adverse events over the course of 3 months of treatment
Recurrence of symptoms within 1 month of cure	1 month after cure	Observe whether the patient has recurrence of tearing and pus overflow symptoms within 1 month after cure
Lacrimal flushing patency at 3 months after the start of treatment	at 3 months after the start of treatment	Whether the tear duct flushing is smooth