干眼理疗仪治疗干眼的多中心随机对照研究

doi:10.3760/cma.j.cn115909-20220207-00049

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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.

Key words： dry eye disease meibomian gland dysfunction eyelid massage eyelid warming moist chamber goggles

Received: 07 February 2022

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Corresponding Authors: Dongqing Zhao, Henan Institute of Ophthalmology, Zhengzhou 450000, China(Email: ykzdq@sina.com)

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	Chao Li1
	Dongqing Zhao2
	Danhong Zhou3
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Cite this article:

Chao Li1,Dongqing Zhao2,Danhong Zhou3等. Multi-Center Randomized Controlled Clinical Study on the Treatment of Dry Eye Disease with Physiotherapy Device[J]. Chinese Journal of Optometry Ophthalmology and Visual science, 2022, 24(5): 370-376.

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https://www.cjoovs.com/EN/ 10.3760/cma.j.cn115909-20220207-00049 OR https://www.cjoovs.com/EN/Y2022/V24/I5/370

[1]	亚洲干眼协会中国分会, 海峡两岸医药卫生交流协会眼科学专业委员会眼表与泪液学组, 中国医师协会眼科医师分会眼表与干眼学组. 中国干眼专家共识: 定义和分类（2020年） . 中华眼科杂志, 2020, 56(6): 418-422. DOI: 10.3760/cma. j.cn112142-20200316-00190.
[2]	Craig JP, Nichols KK, Akpek EK, et al. TFOS DEWS II definition and classification report. Ocul Surf, 2017, 15(3): 276- 283. DOI: 10.1016/j.jtos.2017.05.008.
[3]	Lemp MA, Crews LA, Bron AJ, et al. Distribution of aqueous deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea, 2012, 31(5): 472-478. DOI: 10.1097/ICO.0b013e318225415a.
[4]	Stapleton F, Alves M, Bunya VY, et al. TFOS DEWS II epidemiology report. Ocul Surf, 2017, 15(3): 334-365. DOI: 10.1016/j.jtos.2017.05.003.
[5]	Olson MC, Korb DR, Greiner JV. Increase in tear film lipid layer thickness following treatment with warm compresses in patients with meibomian gland dysfunction. Eye Contact Lens, 2003, 29(2): 96-99. DOI: 10.1097/01.ICL.0000060998.20142.8D.
[6]	Thode AR, Latkany RA. Current and emerging therapeutic strategies for the treatment of meibomian gland dysfunction (MGD). Drugs, 2015, 75(11): 1177-1185. DOI: 10.1007/s40265- 015-0432-8 .
[7]	Toyos R, McGill W, Briscoe D. Intense pulsed light treatment for dry eye disease due to meibomian gland dysfunction; a 3-year retrospective study. Photomed Laser Surg, 2015, 33(1): 41-46. DOI: 10.1089/pho.2014.3819.
[8]	Ren Y, Chen J, Zheng Q, et al. Short-term effect of a developed warming moist chamber goggle for video display terminal associated dry eye. BMC Ophthalmol, 2018, 18(1): 33. DOI: 10.1186/s12886-018-0700-y.
[9]	Li J, Zheng K, Deng Z, et al. Prevalence and risk factors of dry eye disease among a hospital-based population in southeast China. Eye Contact Lens, 2015, 41(1): 44-50. DOI: 10.1097/ ICL.0000000000000064.
[10]	孙一宁, 陈蔚. 关注白内障术后干眼. 中华眼视光学与视觉科学杂志, 2021, 23(7): 486-490. DOI: 10.3760/cma. j.cn115909-20201020-00401.
[11]	Matsumoto Y, Dogru M, Goto E, et al. Efficacy of a new warm moist air device on tear functions of patients with simple meibomian gland dysfunction. Cornea, 2006, 25(6): 644-650. DOI: 10.1097/01.ico.0000208822.70732.25.
[12]	Bilkhu PS, Naroo SA, Wolffsohn JS. Randomised masked clinical trial of the MGDRx EyeBag for the treatment of meibomian gland dysfunction-related evaporative dry eye. Br J Ophthalmol, 2014, 98(12): 1707-1711. DOI: 10.1136/ bjophthalmol-2014-305220.
[13]	Finis D, Hayajneh J, König C, et al. Evaluation of an automated thermodynamic treatment (LipiFlow® ) system for meibomian gland dysfunction: a prospective, randomized, observer masked trial. Ocul Surf, 2014, 12(2): 146-154. DOI: 10.1016/ j.jtos.2013.12.001.
[14]	Sullivan DA, Rocha EM, Aragona P, et al. TFOS DEWS II sex, gender, and hormones report. Ocul Surf, 2017, 15(3): 284-333. DOI: 10.1016/j.jtos.2017.04.001.
[15]	李景兰, 叶子, 马天驹, 等. 玻璃酸钠滴眼液对干眼患者生物测量参数及人工晶状体度数的影响. 中华眼视光学与视觉科学杂志, 2021, 23(7) : 491-499. DOI: 10.3760/cma. j.cn115909-20210216-00061