- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02081781
The Factors That Affected the Outcome of Treatment of Congenital Nasolacrimal Duct Obstruction
March 5, 2014 updated by: Cathay General Hospital
Case Control Study of the Factors That Affected the Outcome of Treatment of Congenital Nasolacrimal Duct Obstruction
The purpose of this study was to investigate various potential factors that affected the outcome of treatment of congenital nasolacrimal duct obstruction.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Congenital nasolacrimal duct obstruction is a common condition during the first few years of childhood.
Most cases may resolve spontaneously, but the remaining children whose blockage does not resolve may require primary probing.
Controversy remains regarding the optimal timing of the probing procedure.
Another controversy is related to the setting of surgery.
Therefore, we try to investigate the factors that affected the outcome of treatment of congenital nasolacrimal duct obstruction under the same surgical doctor during the past 13 years in our hospital.
Study Type
Observational
Enrollment (Actual)
800
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan, 106
- Department of Ophthalmology, Cathay General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 week to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
primary care clinic
Description
Inclusion Criteria:
- a history of tearing and/or mucopurulent discharge beginning during the first few weeks of life
- anatomical nasolacrimal duct obstruction
Exclusion Criteria:
- previous probing
- glaucoma
- trauma
- lid malpositions
- craniofacial anomalies
- congenital mucocele of the nasolacrimal sac
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Probing, topical anesthesia
Nasolacrimal duct obstruction (NLDO) is a quite common condition among the infants.
An imperforate membrane at the distal end of the nasolacrimal duct is the main cause of occlusion.
Children with the signs of NLDO presenting with epiphora and/or mucous discharge were included in this study.
Intervention with probing under topical anesthesia was performed on the same surgeon.
And success rate was evaluated.
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A punctal dilator was used for dilating the punctum.
The nasolacrimal system was irrigated through either the lower or upper punctum with a hollow 23-gauge irrigating cannula attached to a syringe.
A #0 (or #00) Bowman probe was passed through either the lower or upper canaliculus into the lacrimal sac and then directed downward through the nasolacrimal duct into nasal cavity.
A "Hard" resistance could be felt as the probe touched the end of the nasolacrimal duct.
A "Pop" tactile sensation might be noted while the probe passing through an obstruction at the valve of Hasner.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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probing success: both anatomical patency of the duct and functional free of symptoms
Time Frame: one week
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one week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chih Heng Hung, M.D., Department of Ophthalmology, Cathay General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Pediatric Eye Disease Investigator Group, Repka MX, Chandler DL, Beck RW, Crouch ER 3rd, Donahue S, Holmes JM, Lee K, Melia M, Quinn GE, Sala NA, Schloff S, Silbert DI, Wallace DK. Primary treatment of nasolacrimal duct obstruction with probing in children younger than 4 years. Ophthalmology. 2008 Mar;115(3):577-584.e3. doi: 10.1016/j.ophtha.2007.07.030. Epub 2007 Nov 8.
- Miller AM, Chandler DL, Repka MX, Hoover DL, Lee KA, Melia M, Rychwalski PJ, Silbert DI; Pediatric Eye Disease Investigator Group, Beck RW, Crouch ER 3rd, Donahue S, Holmes JM, Quinn GE, Sala NA, Schloff S, Wallace DK, Foster NC, Frick KD, Golden RP, Lambert SR, Tien DR, Weakley DR Jr. Office probing for treatment of nasolacrimal duct obstruction in infants. J AAPOS. 2014 Feb;18(1):26-30. doi: 10.1016/j.jaapos.2013.10.016.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
March 5, 2014
First Submitted That Met QC Criteria
March 5, 2014
First Posted (Estimate)
March 7, 2014
Study Record Updates
Last Update Posted (Estimate)
March 7, 2014
Last Update Submitted That Met QC Criteria
March 5, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CGH-P103002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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