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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ray Kraker, Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT00315315
First received: April 14, 2006
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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.

Condition Intervention Phase
Nasolacrimal Duct Obstruction
Procedure: Nasolacrimal balloon catheter dilation
Procedure: Nasolacrimal intubation
Procedure: Nasolacrimal duct probing
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of Surgical Procedures for the Treatment of Persistent Nasolacrimal Duct Obstruction in Children Less Than Four Years Old

Further study details as provided by Jaeb Center for Health Research:

Enrollment: 194
Study Start Date: February 2005
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   6 Months to 47 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315315

Locations
United States, Maryland
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287-9028
United States, Pennsylvania
Family Eye Clinic
Lancaster, Pennsylvania, United States, 17601
Sponsors and Collaborators
Jaeb Center for Health Research
Investigators
Study Chair: Michael X. Repka, M.D. Wilmer Eye Institute
Study Chair: David I. Silbert, M.D. Family Eye Group
  More Information

Publications:
Responsible Party: Ray Kraker, Director, PEDIG Coordinating Center, Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00315315     History of Changes
Other Study ID Numbers: NEI-117, 2U10EY011751, 5U10EY011751
Study First Received: April 14, 2006
Last Updated: May 16, 2012
Health Authority: United States: Federal Government

Keywords provided by Jaeb Center for Health Research:
Nasolacrimal duct obstruction
Balloon catheter nasolacrimal duct dilation
Nasolacrimal intubation
Simple Nasolacrimal duct probing

ClinicalTrials.gov processed this record on July 08, 2014