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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nasolacrimal Duct Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Immediate Office Probing

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Deferred Facility Probing

Intervention Type PROCEDURE

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

Interventions

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Immediate Office Probing

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

Intervention Type PROCEDURE

Deferred Facility Probing

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

10 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No