A randomized controlled clinical study on amniotic stent and silicone tube implantation through nasolacrimal duct for the treatment of lacrimal duct obstruction disease

Authors: Cui Hua,  Xiao Fan,  Lai Pinghong,  He Yalin,  Zhou Min,  Zhao Jialiang

DOI: 10.3760/cma.j.cn115989-20190610-00253
Published 2020-12-10
Cite as Chin J Exp Ophthalmol, 2020,38(12): 1061-1065.

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.

Key words:

Lacrimal duct obstruction diseases; Amnion lacrimal stent; Silicon tube

Contributor Information

Cui Hua
Departemnt of Ophthalmology, Jiangxi Provincial People’s Hospital, Nanchang 330006, China
Xiao Fan
Departemnt of Ophthalmology, Jiangxi Provincial People’s Hospital, Nanchang 330006, China
Lai Pinghong
Departemnt of Ophthalmology, Jiangxi Provincial People’s Hospital, Nanchang 330006, China
He Yalin
Departemnt of Ophthalmology, Jiangxi Provincial People’s Hospital, Nanchang 330006, China
Zhou Min
Departemnt of Ophthalmology, Jiangxi Provincial People’s Hospital, Nanchang 330006, China
Zhao Jialiang
Departemnt of Ophthalmology, Peking Union Medical College Hospital, Beijing 100010, China
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Updated: December 18, 2020 — 7:50 am