A Randomized Trial Comparing Immediate Probing in an Office Setting With Deferred Probing in a Facility Setting for Treatment of Nasolacrimal Duct Obstruction in Children 6 to <10 Months Old
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Proportion of Participants With Treatment Success
研究概览
简要总结
The purpose of this study is:
To determine the cost-effectiveness of treating NLDO using immediate office probing compared with deferred probing in a facility setting. As part of the primary objective, the study will determine the proportion of eyes experiencing spontaneous resolution among subjects randomized to the deferred probing group.
The secondary objectives are:
- To determine the success proportion for eyes undergoing immediate office probing as an initial procedure.
- To determine the success proportion for eyes undergoing deferred facility probing as an initial procedure.
详细描述
Nasolacrimal duct obstruction (NLDO) is a common ocular condition in the first year of life. Many cases will resolve spontaneously or with massage. Many studies of primary treatment of NLDO have been reported, however these case series have largely been retrospective, uncontrolled, and conducted in single centers. The substantial uncertainty regarding an estimate of spontaneous resolution is a primary reason for conducting the current study.
Probing is the most widely-used initial treatment for NLDO in infancy. Our group recently completed a prospective observational study which found a 78% success proportion of probing among children aged 6 to <12 months. Other estimates of the success rate for probing vary between 69% and 92%.
Two differing approaches to nasolacrimal probing have been most often been used: (1) immediate office probing (early probing - generally soon after 6 months of age) and (2) medical management (episodic antibiotic eye drops with massage of the lacrimal sac) until 9-13 months of age followed by probing under general anesthesia or conscious sedation (deferred probing). The advantages of early probing are the avoidance of general anesthesia or conscious sedation, immediate resolution of symptoms, fewer physician visits, fewer antibiotic prescriptions, lesser cost per procedure, and possible prevention of fibrosis from inflammation in the nasolacrimal duct. The advantages of deferred probing include more subject comfort with the procedure and possible avoidance of a surgical procedure completely.
The optimal approach to the management of NLDO in the first year of life remains uncertain. Our prospective observational data suggest a slightly reduced chance of success with immediate office probing (75% for office probing, 80% for facility probing), however, immediate office probing may be more cost-effective even if the proportion with success is lower. For a subject undergoing a single operation, immediate office probing is less expensive than deferred probing in a facility because there is no fee for anesthesia, the facility, or for medications prescribed during the pre-operative observation period. Some portion of this lower cost would be offset however by the additional cost of a second procedure if the initial office probing is not successful. Deferred facility probing is more expensive per procedure; however, the overall costs are reduced by the number of children whose NLDO spontaneously resolves while waiting to perform the procedure in a facility.
The study is a randomized clinical trial which aims to determine the cost-effectiveness of treating NLDO using immediate office probing compared with deferred probing in a facility setting. As part of the primary objective, the study will determine the proportion of eyes experiencing spontaneous resolution among subjects randomized to the deferred probing group.
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
- None
入排标准
- 年龄范围
- 6 Months 至 10 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 to <10 months
- •Onset of NLDO symptoms and/or signs prior to 6 months chronological age in study eye(s)
- •Presence in study eye(s) of epiphora, increased tear film, and/or mucous discharge in the absence of an upper respiratory infection or an ocular surface irritation that investigator believes is due to NLDO
- •At least one open punctum present in study eye(s)
- •A history of NLDO treatment with lacrimal massage, topical antibiotics or steroids, or systemic antibiotics is permitted.
排除标准
- •History of nasolacrimal duct surgery including probing, nasolacrimal intubation, balloon catheter dilation, or dacryocystorhinostomy in study eye(s) History of trauma to the lacrimal drainage system of the study eye(s)
- •Glaucoma in study eye(s)
- •Corneal surface disease in study eye(s)
- •Microphthalmia in study eye(s)
- •Down Syndrome
- •Craniosynostosis
- •Goldenhar sequence
- •Clefting syndromes
- •Hemifacial microsomia
- •Midline facial anomalies
结局指标
主要结局
Proportion of Participants With Treatment Success
时间窗: 18 months of age
Absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) upon masked examination at 18 months of age.
Cost of Treatment
时间窗: Randomization to 18 months of age
Total cost of treatment including the cost of an initial office consultation and all surgeries received (i.e. initial surgeries and reoperations) and medications prescribed for NLDO between randomization and the 18 months of age visit. Estimates of treatment costs were obtained primarily from the 2011 Medicare Fee Schedules.
次要结局
- Proportion of Participants With Office Probing Success 6 Months After Randomization(Randomization to 6 months)
- Months of Symptoms of Nasolacrimal Duct Obstruction (NLDO) Between Randomization and 18 Months of Age(Randomization to 18 months of age.)
- Proportion of Deferred Facility Probing Group Participants With 6-Month Resolution of NLDO Without Surgery(Randomization to 6 months)