Nasolacrimal Duct Obstruction Clinical Trial
Official title:
A Prospective Study of Primary Surgical Treatment of Nasolacrimal Duct Obstruction in Children Less Than Four Years Old
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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