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Study of Primary Surgical Treatment of Nasolacrimal Duct Obstruction in Children Less Than Four Years Old (NLD1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00315289
Recruitment Status : Completed
First Posted : April 18, 2006
Last Update Posted : March 2, 2010
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by:
Jaeb Center for Health Research

Tracking Information
First Submitted Date April 14, 2006
First Posted Date April 18, 2006
Last Update Posted Date March 2, 2010
Study Start Date February 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Primary Surgical Treatment of Nasolacrimal Duct Obstruction in Children Less Than Four Years Old
Official Title A Prospective Study of Primary Surgical Treatment of Nasolacrimal Duct Obstruction in Children Less Than Four Years Old
Brief 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population community sample
Condition Nasolacrimal Duct Obstruction
Intervention
  • Procedure: Nasolacrimal balloon catheter duct dilation
  • Procedure: Nasolacrimal intubation
  • Procedure: Simple Nasolacrimal duct probing
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 13, 2007)
973
Original Enrollment
 (submitted: April 14, 2006)
800
Actual Study Completion Date September 2006
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • Age 6 - < 48 months
  • Parent/guardian has the ability to complete a written questionnaire
  • For patients with two eyes requiring surgery at enrollment: investigator is planning to perform the same type of surgical procedure on both eyes
  • Onset of NLDO symptoms and/or signs prior to 6 months chronological age
  • Presence of epiphora, increased tear film, and/or mucopurulent discharge in the absence of an upper respiratory infection or an ocular surface irritation
  • Undergoing primary NLDO surgery

Exclusion Criteria:

  • History of nasolacrimal duct surgery including simple probing, nasolacrimal intubation, balloon catheter dilation, or dacryocystorhinostomy
  • Glaucoma present
  • Corneal surface disease
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Months to 47 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00315289
Other Study ID Numbers NEI-116
2U10EY011751 ( U.S. NIH Grant/Contract )
5U10EY011751 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Roy W. Beck, M.D., Ph.D., Jaeb Center for Health Research
Study Sponsor Jaeb Center for Health Research
Collaborators National Eye Institute (NEI)
Investigators
Study Chair: Michael X. Repka, M.D. Wilmer Eye Institute
Study Chair: David I. Silbert, M.D. Family Eye Group
PRS Account Jaeb Center for Health Research
Verification Date January 2010