JRCT ID: jRCT1032230054
Registered date:28/04/2023
the effect of an eye mask eyelid heating device on clinical findings in Patients with meibomian gland dysfunction: controlled before-after study
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | obstructive meibomian gland dysfunction |
Date of first enrollment | 28/04/2023 |
Target sample size | 62 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Wearing an eye mask eyelid heating device (5 minutes at 40 degrees celsius) |
Outcome(s)
Primary Outcome | the Dry Eye Disease Specific Questionnaire (J-OSDI), VAS Score Tear Layer Breakdown Time, Fluorescent Dye Test, Maximum blink interval, Schirmer Test, Meibomian Gland Examination, slit-lamp micrographs |
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Secondary Outcome | Temperature measurement of the eyelid area by thermography |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1. Adults who are 18 years of age or older at the time of obtaining consent 2. Those who have been diagnosed with obstructive meibomian gland dysfunction 3. Subjects who have received a explanation of their participation in this study, and who have given written consent of their own free will based on sufficient understanding |
Exclude criteria | 1. Those who have developed eye allergies 2. Patients with a history of eye surgery 3. Patients with excessive secretion of myvoid gland 4. Have a history of contact lens use for more than 1 year 5. Those who are receiving eye drop treatment (for ocular diseases other than dry eye or myobome gland dysfunction) 6. Other subjects who are deemed inappropriate as research subjects by the principal investigator. |
Related Information
Primary Sponsor | Inomata Takenori |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Yuki Morooka |
Address | Hongo2-1-1, Bunkyo-ku, Tokyo Tokyo Japan 113-8421 |
Telephone | +81-9093308855 |
y.morooka.df@juntendo.ac.jp | |
Affiliation | Juntendo university |
Scientific contact | |
Name | Takenori Inomata |
Address | Hongo2-1-1, Bunkyo-ku, Tokyo Tokyo Japan 113-8421 |
Telephone | +81-3-3813-3111 |
tinomata@juntendo.ac.jp | |
Affiliation | Juntendo university |