AUG 10, 2009
This prospective, nonrandomized multicenter study enrolled 159 children aged 6 to 48 months with persistent nasolacrimal duct obstruction and a history of a single failed nasolacrimal duct probing. They underwent either balloon catheter nasolacrimal duct dilation or nasolacrimal duct intubation within 30 days of the failed probing. After six months, treatment was judged a success-defined by the absence of epiphora, mucous discharge or increased tear lake or another operation-in a similar percentage of both groups: 65 of 84 eyes (77 percent) that underwent balloon catheter dilation and 72 of 88 eyes (84 percent) that underwent nasolacrimal intubation.
The success rate was 90 percent with tubes left in place for two months or longer (ranging up to seven months), compared with 70 percent for those removed earlier, a result that was nonsignificant possibly due to the study's relatively small sample size. Treatment success was similar for monocanalicular versus bicanalicular intubation (79 percent vs. 87 percent).
With the exception of eight patients who were enrolled and randomized before the study was changed from a prospective randomized design, treatment choice was at the discretion of the investigator who performed the surgery. All but 12 percent of investigators performed only one type of procedure on study subjects. The surgeries were conducted by 30 of the study's 50 Pediatric Eye Disease Investigator Group authors, who were predominantly pediatric ophthalmologists and a few ocuplastics subspecialists.