Clininal evaluation of a novel China original liquid pulsation system for meibomian gland dysfunction

Authors: Zhai Zimeng,  Zhang Hong,  Wu Yuqing,  Gong Lan,  Xu Jianjiang,  Zhou Xingtao,  Zhou Feng,  Hong Jiaxu
DOI: 10.3760/cma.j.cn115989-20220801-00357
Published 2023-05-10
Cite as Chin J Exp Ophthalmol, 2023, 41(5): 442-449.

Abstract                              [Download PDF] [Read Full Text]

Objective

To evaluate the efficacy and safety of a China original liquid pulsation system for the treatment of meibomian gland dysfunction (MGD).

Methods

A non-randomized controlled clinical trial was conducted.Twenty-two patients (44 eyes) diagnosed with MGD in Eye and ENT Hospital of Fudan University from February to August 2022 were enrolled.The patients were assigned into two groups according to their willingness.Of the 22 patients (44 eyes), 10 patients (20 eyes) in single liquid pulsation system group were treated with single liquid pulsation system for 12 minutes, and 12 patients (24 eyes) in intense pulsed light (IPL) group were treated with a course (4 times) of IPL, warm compresses and meibomian gland massage at three-week intervals.There was no difference in age and other baseline clinical indexes between the two groups (all at P<0.05). The meibum grading, quality grading of tear film lipid layer, Symptom Assessment Questionnaire in Dry Eye (SANDE) questionnaire score, first and average tear breakup time (BUT), corneal fluorescein sodium staining (CFS) score, tear meniscus height (TMH), and the area of meibomian gland loss were determined at baseline, 1 and 3 months after treatment.This study adhered to the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of Eye and ENT Hospital of Fudan University (No.2021069). Written informed consent was obtained from each patient before any medical examination.

Results

Statistically significant group effects and time effects were found in the quality of tear film lipid layer (Hgroup=4.39, P=0.036, Htime=6.30, P=0.043) and average BUT (Fgroup=4.41, P=0.038; Ftime=4.08, P=0.049) in the two groups.The meibum grading, first BUT and TMH 1 and 3 months after treatment were significantly better than before treatment in single liquid pulsation system group (all at P<0.05). Compared with before treatment, there was no significant improvement in the meibum grading, distribution of tear film lipid, first BUT and TMH at 1 and 3 months after treatment in IPL group (all at P>0.05). In both groups, the SANDE and CFS scores 1 and 3 months after treatment were better than those before treatment, showing statistically significance (all at P<0.05). In terms of safety, neither instrument-related adverse events nor extra complaints of discomfort were reported in the single liquid pulsation system group.In both groups, the number of patients with positive CFS staining significantly decreased, and no new cases with positive CFS appeared after treatment.

Conclusions

This China original liquid pulsation system is a safe and effective physical therapy in improving tear film dysfunction and ocular surface symptoms of MGD patients within 3 months after treatment.

Key words:

Meibomian gland dysfunction; Liquid pulsation system; Treatment outcomes

Contributor Information

Zhai Zimeng

Department of Ophthalmology, Eye and ENT Hospital of Fudan University, Shanghai 200031, China

Zhang Hong

Department of Ophthalmology, Eye and ENT Hospital of Fudan University, Shanghai 200031, China

Wu Yuqing

Department of Ophthalmology, Eye and ENT Hospital of Fudan University, Shanghai 200031, China

Gong Lan

Department of Ophthalmology, Eye and ENT Hospital of Fudan University, Shanghai 200031, China

Xu Jianjiang

Department of Ophthalmology, Eye and ENT Hospital of Fudan University, Shanghai 200031, China

Zhou Xingtao

Institutes of Biomedical Sciences of Fudan University, Shanghai 200032, China

Zhou Feng

Department of Ophthalmology, Eye and ENT Hospital of Fudan University, Shanghai 200031, China

Hong Jiaxu

Department of Ophthalmology, Eye and ENT Hospital of Fudan University, Shanghai 200031, China

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