Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00315289
Status:
COMPLETED
Last Update Posted:
2010-03-02
First Post:
2006-04-14
Brief Title:
Study of Primary Surgical Treatment of Nasolacrimal Duct Obstruction in Children Less Than Four Years Old
Sponsor:
Jaeb Center for Health Research
Organization:
Jaeb Center for Health Research
Study Overview
Official Title:
A Prospective Study of Primary Surgical Treatment of Nasolacrimal Duct Obstruction in Children Less Than Four Years Old
Status:
COMPLETED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NLD1
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
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5U10EY011751 | NIH | None | httpsreporternihgovquickSearch5U10EY011751 |
| 2U10EY011751 | NIH | None | None |