Phase 3
N=163
Immediate Office Probing vs Deferred Facility Probing for Nasolacrimal Duct Obstruction in Children 6 to <10 Months Old
Nasolacrimal Duct Obstruction
Bottom Line
View on ClinicalTrials.gov: NCT00780741 ↗Enrolled (actual)
163
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcome: Primary: Proportion of Participants With Treatment Success — 0.92; 0.82 proportion of participants — p=0.09
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Immediate Office Probing (Procedure); Deferred Facility Probing (Procedure)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Jaeb Center for Health Research
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Treatment Success |
0.92; 0.82 | 0.09 |
| PRIMARY Cost of Treatment |
562; 701 | 0.24 |
| SECONDARY Months of Symptoms of Nasolacrimal Duct Obstruction (NLDO) Between Randomization and 18 Months of Age |
1.8; 4.8 | <0.0001 sig |
| SECONDARY Proportion of Deferred Facility Probing Group Participants With 6-Month Resolution of NLDO Without Surgery |
0.66 | — |
| SECONDARY Proportion of Participants With Office Probing Success 6 Months After Randomization |
0.83 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00780741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.