Study of Surgical Procedures for Treatment of Persistent Nasolacrimal Duct Obstruction in Children < 4 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 for the treatment of persistent nasolacrimal duct
           obstruction for three surgical procedures: balloon catheter dilation, nasolacrimal
           intubation, and simple probing.

        -  To obtain descriptive data regarding symptoms and quality of life in patients receiving
           each type of surgical procedure, and to compare success proportions between patients
           undergoing balloon catheter dilation and those undergoing nasolacrimal intubation.
    

Detailed description: 
      Nasolacrimal duct obstruction (NLDO) is a common ocular condition in the first year of life.
      As many as 95% of cases resolve spontaneously by one year of age. For those children in whom
      the condition does not resolve spontaneously, the initial surgical management is a probing of
      the nasolacrimal duct. Such a procedure is often successful, with cure rates up to 95%,
      especially in the first year of life. However, there are some patients in whom the initial
      procedure is not successful and repeat surgery is needed. Failure of an initial probing is
      thought to be associated with abnormal nasolacrimal anatomy, closure by healing of the
      surgical opening in the nasolacrimal duct, continued occlusion by the inferior turbinate,
      creation of a false passage, or faulty technique.

      Several case series of repeat surgery for nasolacrimal obstruction have been reported. These
      studies have generally been retrospective, uncontrolled, unmasked, and conducted in single
      centers. These studies have also used differing definitions of treatment success, making it
      difficult to compare outcomes between the techniques. There is currently no accepted clinical
      practice for the management of these children. Clinicians choose among repeat probing, repeat
      probing with inferior turbinate infracture, multipass probing, balloon catheter dilation, and
      nasolacrimal duct intubation.

      Repeat probing was for many years the only method available for persistent obstruction.
      However, because the repeat probing procedure was associated with failures, surgeons began to
      probe the nasolacrimal duct and to place a temporary stent in the nasolacrimal duct.
      Nasolacrimal duct intubation has been an alternative to probing for relief of NLDO for more
      than thirty years. Most often, silicone tubes are left in the drainage system for 1 to 3
      months to allow time for complete healing around the tubes resulting in canalization. The
      stent is removed with topical anesthesia. Conscious sedation or general anesthesia may be
      utilized at investigator discretion. The reported success proportions for nasolacrimal
      intubation following failed probing vary from 69% to 100% in published reports.

      More recently, the nasolacrimal probe has been combined with a balloon designed to forcibly
      expand the nasolacrimal duct, a strategy taken from angioplasty. The balloon catheter
      dilation has been available for the past 10 years. This procedure involves probing the
      nasolacrimal duct with a semi-flexible wire probe with an inflatable balloon on the tip. This
      technique has been used as a primary treatment of NLDO as well as a treatment for previous
      surgical failures. Balloon dilation has been promoted as a less complex procedure when
      compared to intubation, because it does not require retrieval of the probe from the nose. An
      additional advantage is that a stent is not left in the nasolacrimal system once the
      procedure is completed, eliminating the post-operative issues regarding removal of the tubes.
      The reported success proportions for balloon catheter dilation vary between 50% to 94% in
      published reports.

      The public health importance of this study is the potential to reduce the total number of
      procedures necessary for NLDO after a failed probing as well as to reduce the need for
      dacryocystorhinostomy (DCR) surgery in children. Reductions in the number of these procedures
      will reduce health care expenditures and would be expected to be associated with a better
      quality of life for the patients.

      The study has been designed as an observational study that largely 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.
    

Intervention name(s): Nasolacrimal balloon catheter dilation; Nasolacrimal intubation; Nasolacrimal duct probing
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Balloon catheter nasolacrimal duct dilation consists of punctal dilation of at least one punctum and the passage into the nose of a semi-flexible wire probe with an inflatable balloon on the tip.; Nasolacrimal duct intubation consists of punctal dilation of at least one punctum with the passage of a flexible lacrimal probe into the nose and the placement of a temporary stent in the nasolacrimal duct.; Simple nasolacrimal duct probing consists of punctal dilation of at least one punctum and the passage of a probe into the nose.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample
      
Keywords: Nasolacrimal duct obstruction; Balloon catheter nasolacrimal duct dilation; Nasolacrimal intubation; Simple Nasolacrimal duct probing