Effects and Safety of Steam Eye Mask With Acupoints Stimulation
NCT ID: NCT04584216
Last Updated: 2020-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2020-05-09
2020-06-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Steam Eye Mask With Acupoints Stimulation
The Steam Eye Mask with acupoints stimulation (SEM with acupoints stimulation), is an eye mask which contains iron (Fe) and generates the heat with the steam (the moist heat) by the oxidative reaction of the iron with oxygen in air.
Also, on the eyebrow have the acupoints made by nonwoven fabric can use hands to massage.
The temperature of the moist heat is approximately 40 degree C and the moist heat lasts for around 20 minutes and use hands to massage the acupoints on the eyebrows for the first 3 minutes.
Steam Eye Mask with acupoints stimulation
A participant needs to use SEM with acupoints stimulation once a day for 10 days and use hands to massage the acupoints on the eyebrows for the first 3 minutes, total application time at least for 20 minutes.
Steam Eye Mask
The Steam Eye Mask (SEM), is an eye mask which contains iron (Fe) and generates the heat with the steam (the moist heat) by the oxidative reaction of the iron with oxygen in air.
The temperature of the moist heat is approximately 40 degree C and the moist heat lasts for around 20 minutes.
Steam Eye Mask
A participant needs to use SEM once a day for 10 days, total application time at least for 20 minutes.
Interventions
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Steam Eye Mask with acupoints stimulation
A participant needs to use SEM with acupoints stimulation once a day for 10 days and use hands to massage the acupoints on the eyebrows for the first 3 minutes, total application time at least for 20 minutes.
Steam Eye Mask
A participant needs to use SEM once a day for 10 days, total application time at least for 20 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants who use VDTs, including laptops, electronic tablets, readers and smartphones for 6 hours or more a day.
3. Participants who respond to the 16 symptoms of visual symptoms related to computer use in the working population for the total score over 6 based on a computer vision syndrome questionnaire.
4. Participants who respond to more than 1 of 12 typical dry eye symptoms by "constantly" or "often" based on a dry eye questionnaire.
5. Participants are able and willing to comply with all protocol requirements and procedures.
6. Participants who must be capable of providing informed consent document, with one's signature.
Exclusion Criteria
2. Participants who have been treated by physicians because of eye diseases and do not recover from that disease yet at the moment of joining to this study, or participants who need to be treated by physicians because of eye disease.
3. Participants with the excessive meibomian lipid secretion (seborrheic MGD).
4. Participants with trauma, swelling and eczema at the skin around eyes.
5. Participants with allergic reaction for heating, abnormality of the heat or depression of the heat.
6. Participants who are deemed inappropriate to participate in this study by physicians.
20 Years
69 Years
ALL
Yes
Sponsors
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Chang Gung Memorial Hospital
OTHER
Kao (Taiwan) Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Yih-Shiou Hwang, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Locations
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Kao (Taiwan) Corporation
Hsinchu, , Taiwan
Countries
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References
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Cushman WH. Reading from microfiche, a VDT, and the printed page: subjective fatigue and performance. Hum Factors. 1986 Feb;28(1):63-73. doi: 10.1177/001872088602800107. No abstract available.
Uchino M, Yokoi N, Uchino Y, Dogru M, Kawashima M, Komuro A, Sonomura Y, Kato H, Kinoshita S, Schaumberg DA, Tsubota K. Prevalence of dry eye disease and its risk factors in visual display terminal users: the Osaka study. Am J Ophthalmol. 2013 Oct;156(4):759-66. doi: 10.1016/j.ajo.2013.05.040. Epub 2013 Jul 24.
Lin PY, Tsai SY, Cheng CY, Liu JH, Chou P, Hsu WM. Prevalence of dry eye among an elderly Chinese population in Taiwan: the Shihpai Eye Study. Ophthalmology. 2003 Jun;110(6):1096-101. doi: 10.1016/S0161-6420(03)00262-8.
Skilling FC Jr, Weaver TA, Kato KP, Ford JG, Dussia EM. Effects of two eye drop products on computer users with subjective ocular discomfort. Optometry. 2005 Jan;76(1):47-54. doi: 10.1016/s1529-1839(05)70254-2.
Odaka A, Toshida H, Ohta T, Tabuchi N, Koike D, Suto C, Murakami A. Efficacy of retinol palmitate eye drops for dry eye in rabbits with lacrimal gland resection. Clin Ophthalmol. 2012;6:1585-93. doi: 10.2147/OPTH.S35584. Epub 2012 Oct 1.
Mori A, Shimazaki J, Shimmura S, Fujishima H, Oguchi Y, Tsubota K. Disposable eyelid-warming device for the treatment of meibomian gland dysfunction. Jpn J Ophthalmol. 2003 Nov-Dec;47(6):578-86. doi: 10.1016/s0021-5155(03)00142-4.
Abramson DI, Tuck S Jr, Lee SW, Richardson G, Levin M, Buso E. Comparison of wet and dry heat in raising temperature of tissues. Arch Phys Med Rehabil. 1967 Dec;48(12):654-61. No abstract available.
Geerling G, Tauber J, Baudouin C, Goto E, Matsumoto Y, O'Brien T, Rolando M, Tsubota K, Nichols KK. The international workshop on meibomian gland dysfunction: report of the subcommittee on management and treatment of meibomian gland dysfunction. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2050-64. doi: 10.1167/iovs.10-6997g. No abstract available.
Segui Mdel M, Cabrero-Garcia J, Crespo A, Verdu J, Ronda E. A reliable and valid questionnaire was developed to measure computer vision syndrome at the workplace. J Clin Epidemiol. 2015 Jun;68(6):662-73. doi: 10.1016/j.jclinepi.2015.01.015. Epub 2015 Jan 28.
Toda I, Fujishima H, Tsubota K. Ocular fatigue is the major symptom of dry eye. Acta Ophthalmol (Copenh). 1993 Jun;71(3):347-52. doi: 10.1111/j.1755-3768.1993.tb07146.x.
Sakane Y, Yamaguchi M, Yokoi N, Uchino M, Dogru M, Oishi T, Ohashi Y, Ohashi Y. Development and validation of the Dry Eye-Related Quality-of-Life Score questionnaire. JAMA Ophthalmol. 2013 Oct;131(10):1331-8. doi: 10.1001/jamaophthalmol.2013.4503.
The epidemiology of dry eye disease: report of the Epidemiology Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):93-107. doi: 10.1016/s1542-0124(12)70082-4.
The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):75-92. doi: 10.1016/s1542-0124(12)70081-2.
Methodologies to diagnose and monitor dry eye disease: report of the Diagnostic Methodology Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):108-52. doi: 10.1016/s1542-0124(12)70083-6.
Shimazaki J, Sakata M, Tsubota K. Ocular surface changes and discomfort in patients with meibomian gland dysfunction. Arch Ophthalmol. 1995 Oct;113(10):1266-70. doi: 10.1001/archopht.1995.01100100054027.
Bron AJ, Benjamin L, Snibson GR. Meibomian gland disease. Classification and grading of lid changes. Eye (Lond). 1991;5 ( Pt 4):395-411. doi: 10.1038/eye.1991.65.
Kim TH, Kang JW, Kim KH, Kang KW, Shin MS, Jung SY, Kim AR, Jung HJ, Choi JB, Hong KE, Lee SD, Choi SM. Acupuncture for the treatment of dry eye: a multicenter randomised controlled trial with active comparison intervention (artificial teardrops). PLoS One. 2012;7(5):e36638. doi: 10.1371/journal.pone.0036638. Epub 2012 May 17.
Murata A., Uetake A., Ostuka M., Takasawa Y., Proposal of an index to evaluate visual fatigue induced during visual display terminal tasks. International Journal of Human-Computer Interaction 13(3): 305-321, 2001.
Wu H.C., Chiu M.C., Jian J.H., Evaluation of Four Eyestrain Recovery Methods for Visual Display Terminal Workers, Communications in Computer and Information Science 617: 536-541, 2016.
Nagashima Y., Effect of autonomic nervous activity of the application of heat- and steam- generating sheets to the eyes [in Japanese]. Jpn J Auton Nervous Syst, 43 260-268, 2006.
Ochiai R., Moist heat stimulation influence on electroencephalograms and the autonomic nervous system [in Japanese]. Jpn J Auton Nervous Syst, 38: 450-454, 2001.
Yang L, Yang Z, Yu H, Song H. Acupuncture therapy is more effective than artificial tears for dry eye syndrome: evidence based on a meta-analysis. Evid Based Complement Alternat Med. 2015;2015:143858. doi: 10.1155/2015/143858. Epub 2015 Apr 16.
Other Identifiers
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Kao-001
Identifier Type: -
Identifier Source: org_study_id
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