NCT00780741

Brief 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. 1.To determine the success proportion for eyes undergoing immediate office probing as an initial procedure.
  2. 2.To determine the success proportion for eyes undergoing deferred facility probing as an initial procedure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2008

Typical duration for phase_3

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

October 1, 2008

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
11 months until next milestone

Results Posted

Study results publicly available

November 12, 2012

Completed
Last Updated

June 24, 2016

Status Verified

May 1, 2016

Enrollment Period

3.1 years

First QC Date

October 27, 2008

Results QC Date

August 23, 2012

Last Update Submit

May 19, 2016

Conditions

Nasolacrimal Duct Obstruction

Keywords

Nasolacrimal duct obstructionSimple probing

Outcome Measures

Primary Outcomes (2)

  • Proportion of Participants With Treatment Success

    Absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) upon masked examination at 18 months of age.

    18 months of age

  • Cost of Treatment

    Total cost of treatment including the cost of an initial office consultation and all surgeries received (i.e. initial surgeries and reoperations) and medications prescribed for NLDO between randomization and the 18 months of age visit. Estimates of treatment costs were obtained primarily from the 2011 Medicare Fee Schedules.

    Randomization to 18 months of age

Secondary Outcomes (3)

  • Months of Symptoms of Nasolacrimal Duct Obstruction (NLDO) Between Randomization and 18 Months of Age

    Randomization to 18 months of age.

  • Proportion of Deferred Facility Probing Group Participants With 6-Month Resolution of NLDO Without Surgery

    Randomization to 6 months

  • Proportion of Participants With Office Probing Success 6 Months After Randomization

    Randomization to 6 months

Study Arms (2)

Immediate Office Probing

ACTIVE COMPARATOR

Probing to be performed in the office setting using topical anesthesia and infant restraint. Probing to be performed either the same day as randomization or within two weeks.

Procedure: Immediate Office Probing

Deferred Facility Probing

ACTIVE COMPARATOR

Probing to be performed in a surgical facility under general anesthesia within four weeks after completion of the 26-week visit if any of the clinical signs persist.

Procedure: Deferred Facility Probing

Interventions

Immediate Office ProbingPROCEDURE

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

Immediate Office Probing
Deferred Facility ProbingPROCEDURE

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

Deferred Facility Probing

Eligibility Criteria

Age6 Months - 10 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 6 to \<10 months
  • Onset of NLDO symptoms and/or signs prior to 6 months chronological age in study eye(s)
  • Presence in study eye(s) of epiphora, increased tear film, and/or mucous discharge in the absence of an upper respiratory infection or an ocular surface irritation that investigator believes is due to NLDO
  • At least one open punctum present in study eye(s)
  • A history of NLDO treatment with lacrimal massage, topical antibiotics or steroids, or systemic antibiotics is permitted.

You may not qualify if:

  • History of nasolacrimal duct surgery including probing, nasolacrimal intubation, balloon catheter dilation, or dacryocystorhinostomy in study eye(s) History of trauma to the lacrimal drainage system of the study eye(s)
  • Glaucoma in study eye(s)
  • Corneal surface disease in study eye(s)
  • Microphthalmia in study eye(s)
  • Down Syndrome
  • Craniosynostosis
  • Goldenhar sequence
  • Clefting syndromes
  • Hemifacial microsomia
  • Midline facial anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intermountain Eye Centers

Boise, Idaho, 83702, United States

Location

Related Publications (4)

  • Pediatric Eye Disease Investigator Group. Resolution of congenital nasolacrimal duct obstruction with nonsurgical management. Arch Ophthalmol. 2012 Jun;130(6):730-4. doi: 10.1001/archophthalmol.2012.454.

    PMID: 22801833BACKGROUND

  • Lee KA, Chandler DL, Repka MX, Melia M, Beck RW, Summers CG, Frick KD, Foster NC, Kraker RT, Atkinson S; PEDIG. A comparison of treatment approaches for bilateral congenital nasolacrimal duct obstruction. Am J Ophthalmol. 2013 Nov;156(5):1045-50. doi: 10.1016/j.ajo.2013.06.014. Epub 2013 Aug 15.

    PMID: 23954210BACKGROUND

  • 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

  • Pediatric Eye Disease Investigator Group. A randomized trial comparing the cost-effectiveness of 2 approaches for treating unilateral nasolacrimal duct obstruction. Arch Ophthalmol. 2012 Dec;130(12):1525-33. doi: 10.1001/archophthalmol.2012.2853.

    PMID: 23229693RESULT

Related Links

MeSH Terms

Conditions

Lacrimal Duct Obstruction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Limitations and Caveats

Conclusions not definitive--would need larger sample size. Participants with bilateral NLDO excluded, so results not generalizable to bilateral cases. Actual costs may vary by region and payer. Did not include costs of follow up visits.

Results Point of Contact

Title
Ray Kraker, Director of PEDIG Coordinating Center
Organization
Jaeb Center for Health Research
rkraker@jaeb.org
813-975-8690

Study Officials

  • Katherine A. Lee, M.D., Ph.D.

    Intermountain Eye Centers

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2008

First Posted

October 28, 2008

Study Start

October 1, 2008

Primary Completion

November 1, 2011

Study Completion

January 1, 2012

Last Updated

June 24, 2016

Results First Posted

November 12, 2012

Record last verified: 2016-05

Locations

US(1)