The Factors That Affected the Outcome of Treatment of Congenital Nasolacrimal Duct Obstruction

Congenital Nasolacrimal Duct Obstruction Clinical Trial

Official title:

Case Control Study of the Factors That Affected the Outcome of Treatment of Congenital Nasolacrimal Duct Obstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02081781
• Other study ID #: CGH-P103002
• Status: Completed
• Phase: N/A
• First received: March 5, 2014
• Last updated: March 5, 2014
• Start date: February 2014
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Cathay General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study was to investigate various potential factors that affected the outcome of treatment of congenital nasolacrimal duct obstruction.

Description:

Congenital nasolacrimal duct obstruction is a common condition during the first few years of childhood. Most cases may resolve spontaneously, but the remaining children whose blockage does not resolve may require primary probing. Controversy remains regarding the optimal timing of the probing procedure. Another controversy is related to the setting of surgery. Therefore, we try to investigate the factors that affected the outcome of treatment of congenital nasolacrimal duct obstruction under the same surgical doctor during the past 13 years in our hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

Inclusion Criteria:

• a history of tearing and/or mucopurulent discharge beginning during the first few weeks of life

• anatomical nasolacrimal duct obstruction

Exclusion Criteria:

• previous probing

• glaucoma

• trauma

• lid malpositions

• craniofacial anomalies

• congenital mucocele of the nasolacrimal sac

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Congenital Nasolacrimal Duct Obstruction

Intervention

Procedure:
• Probing
A punctal dilator was used for dilating the punctum. The nasolacrimal system was irrigated through either the lower or upper punctum with a hollow 23-gauge irrigating cannula attached to a syringe. A #0 (or #00) Bowman probe was passed through either the lower or upper canaliculus into the lacrimal sac and then directed downward through the nasolacrimal duct into nasal cavity. A "Hard" resistance could be felt as the probe touched the end of the nasolacrimal duct. A "Pop" tactile sensation might be noted while the probe passing through an obstruction at the valve of Hasner.

Locations

Country	Name	City	State
Taiwan	Department of Ophthalmology, Cathay General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Cathay General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View Citation

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. Epub 2007 Nov 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	probing success: both anatomical patency of the duct and functional free of symptoms		one week	No