Study of Surgical Procedures for Treatment of Persistent Nasolacrimal Duct Obstruction in Children < 4 Years Old

NCT00315315 | Completed DMC

• 3 other identifiers: NEI-1172U10EY0117515U10EY011751
• Study Type: observational
• Target: 194
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is:

• To report the success proportions for the treatment of persistent nasolacrimal duct obstruction for three surgical procedures: balloon catheter dilation, nasolacrimal intubation, and simple probing.
• To obtain descriptive data regarding symptoms and quality of life in patients receiving each type of surgical procedure, and to compare success proportions between patients undergoing balloon catheter dilation and those undergoing nasolacrimal intubation.

Conditions

Nasolacrimal Duct Obstruction

Keywords

Nasolacrimal duct obstruction; Balloon catheter nasolacrimal duct dilation; Nasolacrimal intubation; Simple Nasolacrimal duct probing

Interventions

Nasolacrimal balloon catheter dilation PROCEDURE

Balloon catheter nasolacrimal duct dilation consists of punctal dilation of at least one punctum and the passage into the nose of a semi-flexible wire probe with an inflatable balloon on the tip.

Nasolacrimal intubation PROCEDURE

Nasolacrimal duct intubation consists of punctal dilation of at least one punctum with the passage of a flexible lacrimal probe into the nose and the placement of a temporary stent in the nasolacrimal duct.

Nasolacrimal duct probing PROCEDURE

Simple nasolacrimal duct probing consists of punctal dilation of at least one punctum and the passage of a probe into the nose.

Eligibility Criteria

• Age: 6 Months - 47 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

• Age 6 - \< 48 months
• Parent/guardian has the ability to complete a written questionnaire
• 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
• Previous single failed simple probing procedure for nasolacrimal duct obstruction
• Investigator has determined the patient requires a second procedure for opening of the nasolacrimal duct

You may not qualify if:

• History of nasolacrimal intubation, balloon catheter dilation, more than one simple probing, or dacryocystorhinostomy
• Glaucoma present
• Corneal surface disease

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• National Eye Institute (NEI): collaborator

Study Sites (2)

Wilmer Eye Institute

Baltimore, Maryland, 21287-9028, United States

Location

Family Eye Clinic

Lancaster, Pennsylvania, 17601, United States

Location

Related Publications (1)

• Repka MX, Chandler DL, Holmes JM, Hoover DL, Morse CL, Schloff S, Silbert DI, Tien DR; Pediatric Eye Disease Investigator Group. Balloon catheter dilation and nasolacrimal duct intubation for treatment of nasolacrimal duct obstruction after failed probing. Arch Ophthalmol. 2009 May;127(5):633-9. doi: 10.1001/archophthalmol.2009.66.

  PMID: 19433712 RESULT

MeSH Terms

Conditions

Lacrimal Duct Obstruction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye 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
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, PEDIG Coordinating Center

Study Record Dates

• First Submitted: April 14, 2006
• First Posted: April 18, 2006
• Study Start: February 1, 2005
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: May 17, 2012

Record last verified: 2012-05

Locations

US (2)