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Home » Resources » Clinical Studies » 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

Clinical Studies Supported by the NEI

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

Purpose | Background | Description | Patient Eligibility | Patient Recruitment Status | Current Status of Study | Results | Publications | Clinical Centers | NEI Representative | Resource Centers

Purpose:

The primary objective of the 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.


Secondary objectives are:
  • To determine the success proportion for eyes undergoing immediate office probing as an initial procedure
  • To determine the success proportion for eyes undergoing deferred facility probing as an initial procedure

    Additional objectives will be detailed in a separate analysis plan.

    Background:

    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. These case series have largely been retrospective, uncontrolled, and conducted in single centers.

    In children with NLDO symptoms, Peterson and Robb found that 58 of 65 (89%) blocked ducts spontaneously resolved by 13 months of age. Peterson and Robb did not report the age distribution for the cohort, but they do note that 67% percent of the spontaneous resolutions occurred before 6 months of age. Nelson and colleagues reported that among 113 infants enrolled into a study between 1 month and 10 months of age (median age = 5 months), 107 (95%) had NLDO spontaneously resolved by 13 months of age. Ghuman and colleagues found spontaneous resolution in 128 (32%) of 402 eyes treated with massage and antibiotics by 13 months, however the ages at which the children had initiated medical management were not specified. Paul reported that among 55 children with infantile NLDO who were first examined at 3 months of age or younger, 51 of 55 (91%) had ducts that were open at 12 months.6 With regard to spontaneous resolution in children who still have NLDO symptoms by a certain age, the Paul report showed that among 37 eyes with NLDO symptoms at 6 months, 26 (70%) were clear without surgical intervention by 12 months of age and that among 23 eyes with NLDO symptoms at 9 months, 12 (52%) had cleared by 12 months. 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% (95% CI = 74% to 82%) success proportion of probing among children aged 6 to <12 months. This overall success proportion was similar to that reported by others, better than the 69% reported by Katowitz and Welsh, though worse than the 92% reported by Robb.

    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 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.

    Both early and deferred probing approaches are usually successful for treatment of NLDO. Early probing done in the office setting with restraint and only topical anesthesia was successful in 92% of children in a retrospective review of a series of 2369 infants. These authors found a decline in success proportions with this office-based approach after 9 months of age. Success proportions of 77% to 97% have been reported in children younger than 18 months with conventional probing with anesthesia. In our previous prospective observational study of probing, 84% of the probings performed in an office setting were done under one year of age and 64% of the probings performed in a surgical facility were done at one year of age or older. The study found that the 239 eyes that underwent office probing procedures had a slightly lower proportion with success (72% [95% CI = 66% to 78%]) compared with the 661 eyes that underwent surgical facility probings (80% [95% CI = 77% to 84%]). Limiting the office probing cohort to the 132 eyes from 105 subjects aged 6 to <10 months old, the proportion with success was 75% (95% CI = 66% to 82%) (PEDIG, unpublished data). We speculated that the lower success with office probings might be due to a less robust procedure (e.g., probe passed only once) being performed in the office setting. However, because our study was not randomized and because the investigators who performed office probings did so nearly exclusively, we could not eliminate the possibility that subject selection bias and/or an investigator effect may be important factors underlying the observed difference in success between the office and facility settings.

    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;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. This has been widely discussed by clinicians and has been studied using clinical decision analysis. Using a hypothetical spontaneous resolution rate of 70%, Kassoff found that deferred facility probing had a higher cost than immediate office probing. In a preliminary model developed with the assistance of Kevin Frick, PhD, we found that a hypothetical spontaneous resolution rate of about 75% equalizes the costs between immediate office probing and deferred facility probing and that a higher spontaneous resolution rate could cause the overall cost to shift in favor of deferred facility probing being less costly (personal communication, 1/17/2008).

    Description:


    Subjects with unilateral or bilateral signs of NLDO will be enrolled and consented prior to randomization.

    Treatment Groups:
    Subjects will be randomized to one of the following groups:

  • Immediate office probing: probing to be performed in the office either the same day as randomization or within two weeks
  • Deferred facility probing: probing to be performed in a facility within four weeks after completion of the 26-week visit if any of the clinical signs persist.

    Visit Schedule:
    The enrollment exam will include an assessment for clinical signs of NLDO, and an ocular exam. Follow up consists of the following visits and scheduled contacts:
  • A phone call 12 (+ 2 weeks) weeks from randomization
  • A visit 26 weeks (+ 2 weeks) from randomization
  • A masked primary outcome exam at 18 months of age (+ 4 weeks)

    Subjects should complete all follow-up exams regardless of whether their symptoms have improved and/or resolved, and regardless of whether they receive surgery.

    Additional visits prior to the primary outcome exam are at investigator discretion.

    Patient Eligibility:



    The following criteria must be met for enrollment into the study:

  • 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.

    The following are 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

    Patient Recruitment Status:

    Not yet recruiting. Comments: Recruitment is expected to start November 2008

    Current Status of Study:

    Comments:

    Results:

    None

    Publications

    None

    Clinical Centers



    For a list of participating centers visit:
    Pediatric Eye Disease Investigator Group website
    URL: http://public.pedig.jaeb.org/myInvestigators.php

    NEI Representative



    Donald F. Everett, M.A.
    National Eye Institute
    National Institutes of Health
    Suite 1300
    5635 Fishers Lane MSC 9300
    Bethesda, MD 20892-9300
    Telephone: (301) 451-2020
    Fax: (301) 402-0528
    Email: deverett@nei.nih.gov

    Resource Centers


    Protocol Chair
    Katherine A. Lee, M.D., Ph.D.
    Intermountain Eye Centers
    222 N. 2nd Street
    Bosie, ID 83702
    USA

    Last Updated: 10/9/2008
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