NCT02081781

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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, 2014

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2014

Completed
Last Updated

March 7, 2014

Status Verified

March 1, 2014

Enrollment Period

28 days

First QC Date

March 5, 2014

Last Update Submit

March 5, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • probing success: both anatomical patency of the duct and functional free of symptoms

    one week

Study Arms (1)

Probing, topical anesthesia

Nasolacrimal duct obstruction (NLDO) is a quite common condition among the infants. An imperforate membrane at the distal end of the nasolacrimal duct is the main cause of occlusion. Children with the signs of NLDO presenting with epiphora and/or mucous discharge were included in this study. Intervention with probing under topical anesthesia was performed on the same surgeon. And success rate was evaluated.

Procedure: Probing

Interventions

ProbingPROCEDURE

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.

Probing, topical anesthesia

Eligibility Criteria

Age1 Week - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic

You may qualify if:

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

You may not qualify if:

  • previous probing
  • glaucoma
  • trauma
  • lid malpositions
  • craniofacial anomalies
  • congenital mucocele of the nasolacrimal sac

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Cathay General Hospital

Taipei, Taiwan, 106, Taiwan

Location

Related Publications (2)

  • 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
  • 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: 24568978BACKGROUND

Study Officials

  • Chih Heng Hung, M.D.

    Department of Ophthalmology, Cathay General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2014

First Posted

March 7, 2014

Study Start

February 1, 2014

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 7, 2014

Record last verified: 2014-03

Locations