A randomized controlled clinical study on amniotic stent and silicone tube implantation through nasolacrimal duct for the treatment of lacrimal duct obstruction disease / 中华实验眼科杂志

ABSTRACT

Objective:To investigate the efficacy and side effects of amnion stent implanted in lacrimal duct for the lacrimal duct obstruction diseases (LDOD).Methods:A randomized controlled clinical trial was adopted.Seventy-two eyes of 72 patients with LDOD treated in Jiangxi Provincial People's Hospital from June 2014 to January 2015 was randomized into the experiment group and the control group with amnion stent or silicone tube retrogradely implanted according to grouping in accordance with block randomization with 36 eyes in each group.All patients were performed irrigation of lacrimal passage at 3 and 6 months postoperatively to compare the patency rate of lacrimal duct and side effects between the two groups.This study followed the Declaration of Helsinki.Written informed consent was obtained from each subject prior to entering the study cohort.The study protocol was approved by the Ethics Committee of Jiangxi Provincial People's Hospital (No.2014-002).Results:The patency rate of lacrimal duct was 91.7%(33/36) and 80.6%(29/36) at 3 months postoperatively in the experimental and control group, respectively.Although the difference was obvious, there was no statistical significance ( P=0.307). The patency rate of lacrimal duct was 88.9%(32/36) and 75.0%(27/36) at 6 months postoperatively in the experimental and control groups, respectively.Similarly, the difference was obvious, however there was no statistical significance ( P=0.220). At 3 months and 6 months postoperatively, the incidence of epiphora in the experimental group was lower than that in the control group, it was significantly different ( Z=2.729, P=0.006), and there was no significant difference at 6 months postoperatively ( Z=1.921, P=0.055). At 6 months follow-up period, the attack rate of side effects, such as dacryon congestion and exudation, was 2.8%(1/36) and 13.9%(5/36) in the experiment and control groups, respectively, however, the difference was no statistical significance ( P=0.199). Conclusions:The implantation of amnion stent in lacrimal duct for LDOD is effective, and the patency rate of lacrimal duct is not lower than that of the implantation of silicone tube in the lacrimal duct.