Study of Primary Surgical Treatment of Nasolacrimal Duct Obstruction in Children Less Than Four Years Old
Condition: Nasolacrimal Duct Obstruction
MeSH terms: Lacrimal Duct Obstruction
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Nasolacrimal balloon catheter duct dilation; Nasolacrimal intubation; Simple Nasolacrimal duct probing
Intervention type(s): Procedure; Procedure; Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        community sample
      
Keywords: Nasolacrimal duct obstruction; Simple probing; Balloon catheter dilation; Nasolacrimal intubation