Immediate Office Probing vs Deferred Facility Probing for Nasolacrimal Duct Obstruction in Children 6 to <10 Months Old (NLD3)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT00780741
First received: October 27, 2008
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

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

Condition Intervention Phase
Nasolacrimal Duct Obstruction
Procedure: Immediate Office Probing
Procedure: Deferred Facility Probing
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Immediate Probing in an Office Setting With Deferred Probing in a Facility Setting for Treatment of Nasolacrimal Duct Obstruction in Children 6 to <10 Months Old

Further study details as provided by Jaeb Center for Health Research:

Primary Outcome Measures:
  • Proportion of Participants With Treatment Success [ Time Frame: 18 months of age ] [ Designated as safety issue: No ]
    Absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) upon masked examination at 18 months of age.

  • Cost of Treatment [ Time Frame: Randomization to 18 months of age ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Months of Symptoms of Nasolacrimal Duct Obstruction (NLDO) Between Randomization and 18 Months of Age [ Time Frame: Randomization to 18 months of age. ] [ Designated as safety issue: No ]
    Months of NLDO symptoms between randomization and 18 months of age. When resolution of NLDO occurred without surgery, the time of resolution was estimated as the midpoint between randomization and the first time point at which symptoms/signs were reported as absent (i.e. 3-month phone call, 6-month visit, or 18 months of age visit) without a subsequent report of symptoms/signs. For patients who underwent successful surgery, months of symptoms was estimated as months between randomization and the surgery. Patients who had clinical signs present at the 18 month of age visit were considered to have had symptoms present since randomization.

  • Proportion of Deferred Facility Probing Group Participants With 6-Month Resolution of NLDO Without Surgery [ Time Frame: Randomization to 6 months ] [ Designated as safety issue: No ]
    Absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) upon unmasked examination 6 months after randomization. Participants who were operated before the 6-month visit were considered treatment failures.

  • Proportion of Participants With Office Probing Success 6 Months After Randomization [ Time Frame: Randomization to 6 months ] [ Designated as safety issue: No ]
    The proportion of immediate office group participants whose office probing was successful when assessed 6 months after randomization. Office probing success was defined as absence of three clinical signs of NLDO (epiphora, increased tear lake, and mucous discharge) 6 months after randomization and no reoperation.


Enrollment: 220
Study Start Date: October 2008
Study Completion Date: January 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Immediate Office Probing
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
Nasolacrimal duct probing in an office setting with topical anesthesia and restraint of the infant.
Active Comparator: Deferred Facility Probing
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
Nasolacrimal duct probing performed under general anesthesia in a hospital outpatient surgery center or an ambulatory surgery center.

Detailed Description:

Nasolacrimal duct obstruction (NLDO) is a common ocular condition in the first year of life. Many cases will resolve spontaneously or with massage. Many studies of primary treatment of NLDO have been reported, however these case series have largely been retrospective, uncontrolled, and conducted in single centers. The substantial uncertainty regarding an estimate of spontaneous resolution is a primary reason for conducting the current study.

Probing is the most widely-used initial treatment for NLDO in infancy. Our group recently completed a prospective observational study which found a 78% success proportion of probing among children aged 6 to <12 months. Other estimates of the success rate for probing vary between 69% and 92%.

Two differing approaches to nasolacrimal probing have been most often been used: (1) immediate office probing (early probing - generally soon after 6 months of age) and (2) medical management (episodic antibiotic eye drops with massage of the lacrimal sac) until 9-13 months of age followed by probing under general anesthesia or conscious sedation (deferred probing). The advantages of early probing are the avoidance of general anesthesia or conscious sedation, immediate resolution of symptoms, fewer physician visits, fewer antibiotic prescriptions, lesser cost per procedure, and possible prevention of fibrosis from inflammation in the nasolacrimal duct. The advantages of deferred probing include more subject comfort with the procedure and possible avoidance of a surgical procedure completely.

The optimal approach to the management of NLDO in the first year of life remains uncertain. Our prospective observational data suggest a slightly reduced chance of success with immediate office probing (75% for office probing, 80% for facility probing), however, immediate office probing may be more cost-effective even if the proportion with success is lower. For a subject undergoing a single operation, immediate office probing is less expensive than deferred probing in a facility because there is no fee for anesthesia, the facility, or for medications prescribed during the pre-operative observation period. Some portion of this lower cost would be offset however by the additional cost of a second procedure if the initial office probing is not successful. Deferred facility probing is more expensive per procedure; however, the overall costs are reduced by the number of children whose NLDO spontaneously resolves while waiting to perform the procedure in a facility.

The study is a randomized clinical trial which aims 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.

  Eligibility

Ages Eligible for Study:   6 Months to 10 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780741

Locations
United States, Idaho
Intermountain Eye Centers
Boise, Idaho, United States, 83702
Sponsors and Collaborators
Jaeb Center for Health Research
Investigators
Study Chair: Katherine A. Lee, M.D., Ph.D. Intermountain Eye Centers
  More Information

Additional Information:
No publications provided by Jaeb Center for Health Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00780741     History of Changes
Other Study ID Numbers: NEI-142, 2U10EY011751
Study First Received: October 27, 2008
Results First Received: August 23, 2012
Last Updated: October 11, 2012
Health Authority: United States: Federal Government

Keywords provided by Jaeb Center for Health Research:
Nasolacrimal duct obstruction
Simple probing

ClinicalTrials.gov processed this record on July 23, 2014