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

NCT00780741 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2016-06-24

Study results available
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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.

Conditions

  • Nasolacrimal Duct Obstruction

Interventions

PROCEDURE

Immediate Office Probing

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

PROCEDURE

Deferred Facility Probing

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

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Katherine A. Lee, M.D., Ph.D. · Intermountain Eye Centers

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
10 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2011-11-30
Completion
2012-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00780741 on ClinicalTrials.gov