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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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.
• Процедура 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

Первичные конечные точки

• Treatment success of congenital tear duct obstruction at 3 months of treatment [Срок оценки: At 3 months of starting treatment]

Вторичные конечные точки (3)

• Lacrimal flushing patency at 3 months after the start of treatment [Срок оценки: at 3 months after the start of treatment]
• Incidence of complications during treatment [Срок оценки: at 3 months after the start of treatment]
• Recurrence of symptoms within 1 month of cure [Срок оценки: 1 month after cure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06924723 · 2025KYPJ036

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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