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Efficacy of probing with mitomycin-c in treatment of nasolacrimal duct obstruction.

Not Applicable
Conditions
asolacrimal duct obstruction.
Registration Number
IRCT2013040310241N1
Lead Sponsor
Jahrom University of Medical Sciences
Brief Summary

The current study aimed to determine the efficacy of probing with adjunctive mitomycin C (MMC) as a treatment for nasolacrimal duct obstruction (NLDO) in adults and to study the association of probing success with demographic and obstruction characteristics. This was a prospective, randomized, double-blind, placebo-controlled trial including 140 patients (each with a unilateral NLDO) scheduled for nasolacrimal probing who were randomly assigned to receive MMC (0.2 mg/ml, 70 patients; group A) or placebo (normal saline, 70 patients; group B). Irrigation was carried out with 0.5 cc of MMC (0.2 mg/mL) in the duct with a nasal pack for 10 minutes in group A. Patients' postprobing epiphora was evaluated at 2 weeks and 1, 3, 6, and 9 months postoperatively. Probing was judged to be a success if there was no or mild watering for at least 9 months after the procedure. There were no significant differences between the two study groups in demographic characteristics or duration of the operation (p=0.062). The overall success rate of probing with MMC was 47/70 (67.1%), which was significantly higher than the success rate of the procedure with placebo (p=0.0027). When the sex of the patients was controlled for by logistic regression, a significant association between the failure rate of probing and increasing age was found in cases and controls (p=0.004 vs. p=0.006, respectively). No significant side effects of probing with MMC were noted after 9 months of follow-up. Administering MMC in a dosage of 0.2 mg/mL during nasolacrimal probing significantly increased the success rate of probing. The failure rate of probing increased with age. A low dose of MMC is cheap, safe, and easily accessible; thus, it is recommended during nasolacrimal probing, especially in patients who refuse dacryocystorhinostomy surgery.<br /> KEYWORDS:<br /> Adult; Lacrimal duct obstruction; Mitomycin

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
140
Inclusion Criteria

1. Adults aged 18 or more.
2. Both sexes of men and women.
3. Patients with chief complaint of epiphora.
Exclusion criteria:
1. Eye trauma.
2. Nasal structure abnormalities.
3. lacrimal system tumors.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Amount of epiphora. Timepoint: Two weeks, 1, 3, 6, and 9 months post intervention. Method of measurement: Observational.
Secondary Outcome Measures
NameTimeMethod
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