Clinical trial NCT00780741: Immediate Office Probing vs Deferred Facility Probing for Nasolacrimal Duct Obstruction in Children 6 to <10 Months Old
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nasolacrimal Duct Obstruction
Keywords: Nasolacrimal duct obstruction
Simple probing
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2008-10-28
Enrollment: 220
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

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 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

Primary outcomes:
measure: Proportion of Participants With Treatment Success
timeFrame: 18 months of age
measure: Cost of Treatment
timeFrame: Randomization to 18 months of age
Secondary outcomes:
measure: Months of Symptoms of Nasolacrimal Duct Obstruction (NLDO) Between Randomization and 18 Months of Age
timeFrame: Randomization to 18 months of age.
measure: Proportion of Deferred Facility Probing Group Participants With 6-Month Resolution of NLDO Without Surgery
timeFrame: Randomization to 6 months
measure: Proportion of Participants With Office Probing Success 6 Months After Randomization
timeFrame: Randomization to 6 months
Other outcomes:
Locations:
city: Boise
country: United States
facility: Intermountain Eye Centers
state: Idaho
Study officials:
affiliation: Intermountain Eye Centers
name: Katherine A. Lee, M.D., Ph.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.