Status:
COMPLETED
Study of Primary Surgical Treatment of Nasolacrimal Duct Obstruction in Children Less Than Four Years Old
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Nasolacrimal Duct Obstruction
Eligibility:
All Genders
6-47 years
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...
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 du...
Eligibility Criteria
Inclusion
- Age 6 - \< 48 months
- Parent/guardian has the ability to complete a written questionnaire
- For patients with two eyes requiring surgery at enrollment: investigator is planning to perform the same type of surgical procedure on both eyes
- 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
- Undergoing primary NLDO surgery
Exclusion
- History of nasolacrimal duct surgery including simple probing, nasolacrimal intubation, balloon catheter dilation, or dacryocystorhinostomy
- Glaucoma present
- Corneal surface disease
Key Trial Info
Start Date :
February 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
973 Patients enrolled
Trial Details
Trial ID
NCT00315289
Start Date
February 1 2005
End Date
September 1 2006
Last Update
March 2 2010
Active Locations (2)
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1
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287-9028
2
Family Eye Clinic
Lancaster, Pennsylvania, United States, 17601