Immediate Office Probing vs Deferred Facility Probing for Nasolacrimal Duct Obstruction in Children 6 to <10 Months Old

Completed · Phase 3

Conditions studied: Nasolacrimal Duct Obstruction

In brief

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 objective, the study will determine the proportion of eyes experiencing spontaneous resolution among subjects randomized to the deferred probing group. The secondary objectives are: 1. To determine the success proportion for eyes undergoing immediate office probing as an initial procedure. 2. To determine the success proportion for eyes undergoing deferred facility probing as an initial procedure.

Key facts

Study ID

NCT00780741

Run by

Jaeb Center for Health Research

People needed

220

Starts

2008-10-01

Expected to finish

2012-01-01

Last updated by the study team

2016-06-24

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Intermountain Eye Centers — Boise, Idaho, United States

Full record on ClinicalTrials.gov

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