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NCT Number: NCT06924723

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

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.

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Key information

Conditions

Nasolacrimal Duct Obstruction Eye Diseases Lacrimal Apparatus Diseases Lacrimal Duct Obstruction

Age range

3 month–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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.

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).

Primary outcomes

  1. Treatment success of congenital tear duct obstruction at 3 months of treatment

    Time frame: 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 outcomes

  1. Lacrimal flushing patency at 3 months after the start of treatment

    Time frame: at 3 months after the start of treatment

    Whether the tear duct flushing is smooth

  2. Incidence of complications during treatment

    Time frame: at 3 months after the start of treatment

    Counting adverse events over the course of 3 months of treatment

  3. Recurrence of symptoms within 1 month of cure

    Time frame: 1 month after cure

    Observe whether the patient has recurrence of tearing and pus overflow symptoms within 1 month after cure

Study contacts

Contact information is provided by the study sponsor or research team.

Xuanwei Liang

CONTACT

[email protected]

+8613694220662

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Official study title

Effect of Standardized Lacrimal Sac Massage Compared With Probing for Congenital Lacrimal Duct Obstruction: a Non-inferiority, Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 11, 2025
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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