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Study of Surgical Procedures for Treatment of Persistent Nasolacrimal Duct Obstruction in Children < 4 Years Old (NLD2)

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ClinicalTrials.gov Identifier: NCT00315315
Recruitment Status : Completed
First Posted : April 18, 2006
Last Update Posted : May 17, 2012
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Ray Kraker, Jaeb Center for Health Research

Tracking Information
First Submitted Date April 14, 2006
First Posted Date April 18, 2006
Last Update Posted Date May 17, 2012
Study Start Date February 2005
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00315315 on ClinicalTrials.gov Archive Site
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 Surgical Procedures for Treatment of Persistent Nasolacrimal Duct Obstruction in Children < 4 Years Old
Official Title A Prospective Study of Surgical Procedures for the Treatment of Persistent Nasolacrimal Duct Obstruction in Children Less Than Four Years Old
Brief 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.

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 dilation
    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.
  • Procedure: Nasolacrimal intubation
    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.
  • Procedure: Nasolacrimal duct probing
    Simple nasolacrimal duct probing consists of punctal dilation of at least one punctum and the passage of a probe into the nose.
Study Groups/Cohorts Not Provided
Publications * Repka MX, Chandler DL, Holmes JM, Hoover DL, Morse CL, Schloff S, Silbert DI, Tien DR; Pediatric Eye Disease Investigator Group. Balloon catheter dilation and nasolacrimal duct intubation for treatment of nasolacrimal duct obstruction after failed probing. Arch Ophthalmol. 2009 May;127(5):633-9. doi: 10.1001/archophthalmol.2009.66.

*   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: December 21, 2007)
194
Original Enrollment
 (submitted: April 14, 2006)
640
Actual Study Completion Date February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age 6 - < 48 months
  • Parent/guardian has the ability to complete a written questionnaire
  • 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
  • Previous single failed simple probing procedure for nasolacrimal duct obstruction
  • Investigator has determined the patient requires a second procedure for opening of the nasolacrimal duct

Exclusion Criteria:

  • History of nasolacrimal intubation, balloon catheter dilation, more than one simple probing, 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 NCT00315315
Other Study ID Numbers NEI-117
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 Ray Kraker, 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 May 2012