Nasolacrimal Duct Obstruction Clinical Trial
Official title:
A Prospective Study of Surgical Procedures for the Treatment of Persistent Nasolacrimal Duct Obstruction in Children Less Than Four Years Old
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.
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.
;
Observational Model: Cohort, Time Perspective: Prospective
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