Status:
COMPLETED
Immediate Office Probing vs Deferred Facility Probing for Nasolacrimal Duct Obstruction in Children 6 to <10 Months Old
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Nasolacrimal Duct Obstruction
Eligibility:
All Genders
6-10 years
Phase:
PHASE3
Brief Summary
The purpose of this study is: To determine the cost-effectiveness of treating NLDO using immediate office probing compared with deferred probing in a facility setting. As part of the primary objectiv...
Detailed Description
Nasolacrimal duct obstruction (NLDO) is a common ocular condition in the first year of life. Many cases will resolve spontaneously or with massage. Many studies of primary treatment of NLDO have been ...
Eligibility Criteria
Inclusion
- Age 6 to \<10 months
- Onset of NLDO symptoms and/or signs prior to 6 months chronological age in study eye(s)
- Presence in study eye(s) of epiphora, increased tear film, and/or mucous discharge in the absence of an upper respiratory infection or an ocular surface irritation that investigator believes is due to NLDO
- At least one open punctum present in study eye(s)
- A history of NLDO treatment with lacrimal massage, topical antibiotics or steroids, or systemic antibiotics is permitted.
Exclusion
- History of nasolacrimal duct surgery including probing, nasolacrimal intubation, balloon catheter dilation, or dacryocystorhinostomy in study eye(s) History of trauma to the lacrimal drainage system of the study eye(s)
- Glaucoma in study eye(s)
- Corneal surface disease in study eye(s)
- Microphthalmia in study eye(s)
- Down Syndrome
- Craniosynostosis
- Goldenhar sequence
- Clefting syndromes
- Hemifacial microsomia
- Midline facial anomalies
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00780741
Start Date
October 1 2008
End Date
January 1 2012
Last Update
June 24 2016
Active Locations (1)
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1
Intermountain Eye Centers
Boise, Idaho, United States, 83702