Study of Primary Surgical Treatment of Nasolacrimal Duct Obstruction in Children Less Than Four Years Old (NLD1)
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|ClinicalTrials.gov Identifier: NCT00315289|
Recruitment Status : Completed
First Posted : April 18, 2006
Last Update Posted : March 2, 2010
The purpose of this study is:
- To report the success proportions of simple probing within different age groups of patients under 24 months of age.
- To obtain descriptive data regarding symptoms and quality of life in patients receiving simple probing.
- To obtain similar data for simple probing in patients 24 months of age or older, for intubation in patients age 6 - <48 months, and for balloon catheter dilation in patients age 6 - <48 months.
|Condition or disease||Intervention/treatment||Phase|
|Nasolacrimal Duct Obstruction||Procedure: Nasolacrimal balloon catheter duct dilation Procedure: Nasolacrimal intubation Procedure: Simple Nasolacrimal duct probing||Phase 3|
Nasolacrimal duct obstruction (NLDO) is a common ocular condition in the first year of life. Most cases will resolve spontaneously or with massage. Many studies of primary treatment of nasolacrimal duct obstruction have been reported. These case series have largely been retrospective, uncontrolled, and conducted in single centers.
Simple probing is the most widely-used initial treatment for NLDO in infancy. Two differing approaches to simple probing have been most often been used, immediate office probing (early probing-generally after 6 months of age), and medical management (episodic antibiotic drops with massage of the lacrimal sac) until 9-13 months of age followed by probing under general anesthesia (late probing). The possible advantages of early probing are the avoidance of general anesthesia, immediate resolution of symptoms, lesser cost, and prevention of fibrosis from inflammation in the nasolacrimal duct. The advantages of late probing include more comfort with the procedure and the avoidance of the procedure completely. Both early and late probing approaches are usually successful for treatment of NLDO in patients under 2 years of age, with reported success proportions varying from between 54% to 98%. Although a number of studies have found that probing was highly successful and without an age-related decline until at least 4 years of age and beyond, there is a suspicion among other clinicians of a clinically-important decline in the success proportions among progressively older age groups of preschool children. A large prospective interventional case series might help to clarify whether there is an age-related decline in success.
Balloon catheter dilation has become popular for the initial surgical treatment of NLDO especially in children older than one year. This procedure involves probing of the nasolacrimal duct with a semiflexible wire probe with an inflatable balloon on the tip.
Nasolacrimal intubation has been used for primary treatment by clinicians in older children or when the duct feels tight. While generally successful, there is less certainty of the success proportions for this procedure when performed as a primary treatment. It is also unknown how often this procedure is used for initial treatment.
Probing of the nasolacrimal duct for the repair of NLDO is a very successful procedure in infancy and childhood. Simple probing has long been the standard approach, though the age at which the procedure declines in effectiveness is controversial. Clinicians have been urged by manufacturers of medical equipment to consider intubation and balloon dilation even in the age range in which probing is highly successful, to further increase the chance of success.
A prospective non-randomized study of the outcomes from many centers of all strategies might allow better estimates of success for the techniques most often used over an extended age range. Such a study might help to define factors associated with failure of each of the techniques.
The study has been designed as an observational study that approximates standard clinical practice. All procedures are consistent with standard care with the exception of a questionnaire which the patient's parent will complete at each study visit on NLDO symptoms and quality of life. The surgical center is not engaged in the research and no data will be collected by surgical personnel.
Treatment success is defined as the absence of any clinical signs of nasolacrimal duct obstruction: presence of epiphora, increased tear film, or mucous discharge.
|Study Type :||Observational|
|Actual Enrollment :||973 participants|
|Official Title:||A Prospective Study of Primary Surgical Treatment of Nasolacrimal Duct Obstruction in Children Less Than Four Years Old|
|Study Start Date :||February 2005|
|Study Completion Date :||September 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315289
|United States, Maryland|
|Wilmer Eye Institute|
|Baltimore, Maryland, United States, 21287-9028|
|United States, Pennsylvania|
|Family Eye Clinic|
|Lancaster, Pennsylvania, United States, 17601|
|Study Chair:||Michael X. Repka, M.D.||Wilmer Eye Institute|
|Study Chair:||David I. Silbert, M.D.||Family Eye Group|