Effect of Standardized Lacrimal Sac Massage Compared With Probing for Congenital Lacrimal Duct Obstruction: a Non-inferiority, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 主要终点
- Treatment success of congenital tear duct obstruction at 3 months of treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
研究组 & 干预措施
control subjects
干预措施: tear duct probing (Procedure)
experimental group
干预措施: Lacrimal sac massage (Procedure)
结局指标
主要结局
Treatment success of congenital tear duct obstruction at 3 months of treatment
时间窗: 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)
次要结局
- 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)
- Lacrimal flushing patency at 3 months after the start of treatment(at 3 months after the start of treatment)