NCT00315289

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 quality of life in patients receiving simple probing.
  • To obtain similar data for simple probing in patients 24 months of age or older, for intubation in patients age 6 - \<48 months, and for balloon catheter dilation in patients age 6 - \<48 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
973

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2005

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 18, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

March 2, 2010

Status Verified

January 1, 2010

First QC Date

April 14, 2006

Last Update Submit

February 26, 2010

Conditions

Nasolacrimal Duct Obstruction

Keywords

Nasolacrimal duct obstructionSimple probingBalloon catheter dilationNasolacrimal intubation

Interventions

Nasolacrimal balloon catheter duct dilationPROCEDURE
Nasolacrimal intubationPROCEDURE
Simple Nasolacrimal duct probingPROCEDURE

Eligibility Criteria

Age6 Months - 47 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • 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

You may not qualify if:

  • History of nasolacrimal duct surgery including simple probing, nasolacrimal intubation, balloon catheter dilation, or dacryocystorhinostomy
  • Glaucoma present
  • Corneal surface disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wilmer Eye Institute

Baltimore, Maryland, 21287-9028, United States

Location

Family Eye Clinic

Lancaster, Pennsylvania, 17601, United States

Location

Related Publications (3)

  • Pediatric Eye Disease Investigator Group; Repka MX, Chandler DL, Beck RW, Crouch ER 3rd, Donahue S, Holmes JM, Lee K, Melia M, Quinn GE, Sala NA, Schloff S, Silbert DI, Wallace DK. Primary treatment of nasolacrimal duct obstruction with probing in children younger than 4 years. Ophthalmology. 2008 Mar;115(3):577-584.e3. doi: 10.1016/j.ophtha.2007.07.030. Epub 2007 Nov 8.

    PMID: 17996306BACKGROUND

  • Pediatric Eye Disease Investigator Group; Repka MX, Melia BM, Beck RW, Chandler DL, Fishman DR, Goldblum TA, Holmes JM, Perla BD, Quinn GE, Silbert DI, Wallace DK. Primary treatment of nasolacrimal duct obstruction with balloon catheter dilation in children younger than 4 years of age. J AAPOS. 2008 Oct;12(5):451-5. doi: 10.1016/j.jaapos.2008.07.001.

    PMID: 18929305BACKGROUND

  • Miller AM, Chandler DL, Repka MX, Hoover DL, Lee KA, Melia M, Rychwalski PJ, Silbert DI; Pediatric Eye Disease Investigator Group; Beck RW, Crouch ER 3rd, Donahue S, Holmes JM, Quinn GE, Sala NA, Schloff S, Wallace DK, Foster NC, Frick KD, Golden RP, Lambert SR, Tien DR, Weakley DR Jr. Office probing for treatment of nasolacrimal duct obstruction in infants. J AAPOS. 2014 Feb;18(1):26-30. doi: 10.1016/j.jaapos.2013.10.016.

    PMID: 24568978DERIVED

MeSH Terms

Conditions

Lacrimal Duct Obstruction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Michael X. Repka, M.D.

    Wilmer Eye Institute

    STUDY CHAIR

  • David I. Silbert, M.D.

    Family Eye Group

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 14, 2006

First Posted

April 18, 2006

Study Start

February 1, 2005

Study Completion

September 1, 2006

Last Updated

March 2, 2010

Record last verified: 2010-01

Locations

US(2)