Study of Surgical Procedures for Treatment of Persistent Nasolacrimal Duct Obstruction in Children < 4 Years Old (NLD2)
|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: NCT00315315|
Recruitment Status : Completed
First Posted : April 18, 2006
Last Update Posted : May 17, 2012
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 or disease||Intervention/treatment|
|Nasolacrimal Duct Obstruction||Procedure: Nasolacrimal balloon catheter dilation Procedure: Nasolacrimal intubation Procedure: Nasolacrimal duct probing|
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|
|Actual Enrollment :||194 participants|
|Official Title:||A Prospective Study of Surgical Procedures for the Treatment of Persistent Nasolacrimal Duct Obstruction in Children Less Than Four Years Old|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315315
|United States, Maryland|
|Wilmer Eye Institute|
|Baltimore, Maryland, United States, 21287-9028|
|United States, Pennsylvania|
|Family Eye Clinic|
|Lancaster, Pennsylvania, United States, 17601|
|Study Chair:||Michael X. Repka, M.D.||Wilmer Eye Institute|
|Study Chair:||David I. Silbert, M.D.||Family Eye Group|