1 Department of Ophthalmology, Suzhou Kowloon Hospital Affiliated to Medical College of Shanghai Jiaotong University, Suzhou 215021, China
2 Henan Institute of Ophthalmology, Zhengzhou 450000, China
3 Department of Ophthalmology, Affiliated Hospital of Jiangnan University, Wuxi 214100, China
Abstract：Objective: To evaluate the clinical safety and effectiveness of a dry eye physiotherapy instrument in the treatment of dry eyes. Methods: This was a prospective, multicenter, randomized controlled clinical study. Eligible patients with mild and moderate dry eyes in Henan Institute of Ophthalmology, Suzhou Kowloon Hospital and Affiliated Hospital of Jiangnan University from July to November 2018 were randomly divided into control group and experimental group. The control group were treated with 0.1% sodium hyaluronate eye drops 4 times a day, 1 drop each time for 4 weeks (28±5 days). The experimontd group were treated with dry eye physiotherapy instrument once a day for at least 15 minutes for 4 weeks (28±5 days). The ocular surface of patients were evaluated before treatment and 1 week, 2 weeks and 4 weeks after treatment, and their effectiveness was analyzed; The subjective symptoms of dry eye, tear film rupture time (BUT), Schirmer I test and corneal fluorescein sodium staining were evaluated before and 4 weeks after treatment. The total symptom score was calculated and the effective rate was analyzed. The measurement data were compared by t-test or Wilcoxon rank sum test, and the constituent ratio and efficiency were compared by Chi square test or Fisher exact probability method. Non inferiority verification method was used to compare the difference between the two groups, and the non inferiority limit was set as Δ= 10%, if the lower 95% confidence interval of the difference between the treatment effective rate of the control group and that of the experimental group is greater than-Δ (-10%), it is inferred that the curative effect of the experimental group is not inferior to that of the control group. Results: One hundred and twelve patients were involved, including 41 males and 71 females; and, there was no significant difference in the total score of symptoms and the ocular surface conditions between both eyes of the two groups in the baseline. In the follow-up population, there was no significant difference in ocular surface conditions between the two groups after 1 week, 2 weeks and 4 weeks of treatmen (right: t=0.15, P=0.880; left: t=0.19, P=0.850). After 4 weeks of treatment, there was no significant difference in the total score of symptoms between both eyes of the two groups (right: t=0.20, P=0.840; left: t=0.43, P=0.670). The effective rate of the experimontd group was 72.7%, while that of the control group was 64.8% and there was no significant difference between them (P>0.05). There were 2 adverse events in the experimental group and 1 adverse event in the control group, the difference was not statistically significant. Conclusion: The effective rate of eye physiotherapy device is 72.7% in treatment of mild or moderate dry eyes, which is not inferior to 0.1% sodium hyaluronate eye drops, and has high safety.
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