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Clinical Trials |

A Randomized Trial Comparing the Cost-effectiveness of 2 Approaches for Treating Unilateral Nasolacrimal Duct Obstruction

Arch Ophthalmol. 2012;130(12):1525-1533. doi:10.1001/archophthalmol.2012.2853.
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Objective To compare the cost-effectiveness of 2 approaches for treating unilateral nasolacrimal duct obstruction (NLDO).

Methods One hundred sixty-three infants aged 6 to less than 10 months with unilateral NLDO were randomly assigned to receive immediate office-based nasolacrimal duct probing (n = 82) or 6 months of observation/nonsurgical management (n = 81) followed by probing in a facility for persistent symptoms.

Main Outcome Measures Treatment success was defined as the absence of clinical signs of NLDO (epiphora, increased tear lake, mucous discharge) on masked examination at age 18 months. Cost of treatment between randomization and age 18 months included costs for all surgical procedures and medications.

Results In the observation/deferred facility-probing group, NLDO resolved within 6 months without surgery in 44 of the 67 patients (66%; 95% CI, 54% to 76%) who completed the 6-month visit. Twenty-two (27%) of the 81 patients in the observation/deferred facility-probing group underwent surgery, 4 of whom were operated on within the initial 6 months. At age 18 months, 69 of 75 patients (92%) in the immediate office-probing group were treatment successes, compared with 58 of 71 observation/deferred facility-probing group patients (82%) (10% difference in success; 95% CI, –1% to 21%). The mean cost of treatment was $562 in the immediate office-probing group compared with $701 in the observation/deferred facility-probing group (difference, –$139; 95% CI, –$377 to $94). The immediate office-probing group experienced 3.0 fewer months of symptoms (95% CI, –1.8 to −4.0).

Conclusions The immediate office-probing approach is likely more cost-effective than observation followed by deferred facility probing if needed. Adoption of the immediate office-probing approach would result in probing in approximately two-thirds of infants whose obstruction would have resolved within 6 months of nonsurgical management, but would largely avoid the need for probing under general anesthesia.

Application to Clinical Practice Although unilateral NLDO often resolves without surgery, immediate office probing is an effective and potentially cost-saving treatment option.

Trial Registration clinicaltrials.gov Identifier: NCT00780741

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Figure 1. Comparison of immediate office-probing and deferred facility-probing groups with primary outcome at age 18 months, probability of following specified pathway, average months of symptoms (Sx) between randomization and age 18 months, and average cost of treatment between randomization and 18 months of age. A, Data on patients assigned to immediate office-probing approach. Numbers decreased over time because 7 patients were lost to follow-up. *All initial surgical procedures were nasolacrimal duct probings performed in the office. †All 7 reoperations occurred in a facility (ambulatory surgery center [ASC] or hospital outpatient department [HOPD])—1 was a probing and 6 were intubations. B, Data on patients assigned to observation/deferred facility-probing approach. Numbers decreased over time because 10 patients were lost to follow-up. ‡Obstruction appeared to resolve in 1 patient at the 6-month visit but intubation was performed before age 18 months. §One deferred surgery was an office probing, 1 was a balloon catheter dilation, and 15 were facility probings. ∥Five patients in the observation/deferred facility-probing group had clinical signs of nasolacrimal duct obstruction at the 6-month visit but did not receive surgery (symptoms resolved before the scheduled surgery or the surgeon and/or parents believed that the surgery was not warranted). ¶Of the 4 operations performed within the first 6 months after randomization, 2 were office probings, 1 was facility intubation, and 1 was facility balloon catheter dilation. #The reoperation was a balloon catheter dilation. NA indicates not applicable.

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Figure 2. Cost-effectiveness analysis. A, Cost-effectiveness for treatment success at age 18 months. The scatterplot indicates the extent of uncertainty in the observed cost-effectiveness estimate. Each point represents the incremental cost-effectiveness derived using 1 of the 10 000 bootstrap samples. X indicates the observed incremental cost-effectiveness for the treatment success outcome (the immediate office-probing approach is 10% more successful and costs $139 less than the observation/deferred facility-probing approach). B, Cost-effectiveness for months of nasolacrimal duct obstruction symptoms between randomization and age 18 months. The scatterplot indicates the extent of uncertainty in the observed cost-effectiveness estimate. Each point represents the incremental cost-effectiveness derived using 1 of the 10 000 bootstrap samples. X indicates the observed incremental cost-effectiveness for the months of symptoms outcome (the immediate office-probing approach has 3.0 fewer months of symptoms and costs $139 less than the observation/deferred facility-probing approach).

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