CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 220 enrolled
Drug / intervention
Immediate Office Probing +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00780741
NCT00780741Phase 3Completed
CompareCT.gov

A Randomized Trial Comparing Immediate Probing in an Office Setting With Deferred Probing in a Facility Setting for Treatment of Nasolacrimal Duct Obstruction in Children 6 to <10 Months Old

Jaeb Center for Health Research·interventional·Posted Oct 28, 2008·Updated Jun 24, 2016

In Brief

A Phase 3 clinical trial evaluating Immediate Office Probing and Deferred Facility Probing for Nasolacrimal Duct Obstruction. Completed, enrolled 220 participants across 1 site.

Detailed 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 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasolacrimal Duct Obstruction
CountriesUnited States
CollaboratorsNational Eye Institute (NEI)

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 28, 2008
Enrollment StartOct 1, 2008
Primary CompletionNov 1, 2011
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 17.7 years ago

Interventions

Immediate Office Probingprocedure

Nasolacrimal duct probing in an office setting with topical anesthesia and restraint of the infant.

Deferred Facility Probingprocedure

Nasolacrimal duct probing performed under general anesthesia in a hospital outpatient surgery center or an ambulatory surgery center.