Immediate Office Probing vs Deferred Facility Probing for Nasolacrimal Duct Obstruction in Children 6 to <10 Months Old
Condition: Nasolacrimal Duct Obstruction
MeSH terms: Lacrimal Duct Obstruction
Study type: Interventional
Phase: Phase 3

Summary: 
      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:

        1. To determine the success proportion for eyes undergoing immediate office probing as an
           initial procedure.

        2. To determine the success proportion for eyes undergoing deferred facility probing as an
           initial procedure.
    

Detailed description: 
      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.
    

Intervention name(s): Immediate Office Probing; Deferred Facility Probing
Intervention type(s): Procedure; Procedure
Intervention description(s): Nasolacrimal duct probing in an office setting with topical anesthesia and restraint of the infant.; Nasolacrimal duct probing performed under general anesthesia in a hospital outpatient surgery center or an ambulatory surgery center.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nasolacrimal duct obstruction; Simple probing