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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000048558
Receipt No. R000055328
Scientific Title Effect of intraocular pressure with facial mask
Date of disclosure of the study information 2022/08/03
Last modified on 2022/08/03

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Basic information
Public title Effect of intraocular pressure with facial mask
Acronym Effect of intraocular pressure with facial mask
Scientific Title Effect of intraocular pressure with facial mask
Scientific Title:Acronym Effect of intraocular pressure with facial mask
Region
Asia(except Japan)

Condition
Condition glaucoma and non-glaucoma patients
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Surgical masks were recommended to prevent COVID-19 transmission, but the effect on intraocular pressure (IOP) remain unknown. This study aimed to investigate the effect of wearing a surgical mask on IOP.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The IOP difference with mask and without mask.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 with and without wearing the surgical mask for 5 minutes in an individual
with mask-->without mask
Interventions/Control_2 with and without wearing the surgical mask for 5 minutes in an individual
without mask-->with mask
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria age over 20-year-old
Key exclusion criteria people who had cornea or other eye diseases that cannot perform intraocular pressure measurement
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Shao-Yu
Middle name
Last name Sung
Organization Kaohsiung Medical University Hospital
Division name Department of Ophthalmology
Zip code 807
Address 100,Shih-Chuan 1st Road,Kaohsiung, Taiwan
TEL +886-7-3121101
Email sysung52@gmail.com

Public contact
Name of contact person
1st name Shao-Yu
Middle name
Last name Sung
Organization Kaohsiung Medical University Hospital
Division name Department of Ophthalmology
Zip code 807
Address 100,Shih-Chuan 1st Road,Kaohsiung, Taiwan
TEL +886-7-3121101
Homepage URL
Email sysung52@gmail.com

Sponsor
Institute Kaohsiung Medical University Hospital
Institute
Department

Funding Source
Organization not applicable
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kaohsiung Medical University Hospital Institutional Review Board
Address 100,Shih-Chuan 1st Road,Kaohsiung, Taiwan
Tel +886-7-3121101
Email irb-meeting@kmuh.org.tw

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2022 Year 08 Month 03 Day

Related information
URL releasing protocol not applicable
Publication of results Unpublished

Result
URL related to results and publications not applicable
Number of participants that the trial has enrolled 174
Results Wearing a surgical mask caused 0.45mmHg increment in intraocular pressure (p<0.001) regardless of age, gender, the diagnosis of glaucoma, or the sequence of surgical mask-wearing. Men were more vulnerable to the effect of surgical masks on IOP values than women.
Results date posted
2022 Year 08 Month 03 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 174 (103 females and 71 males, between 18 and 90 years of age)
Participant flow not applicable
Adverse events not applicable
Outcome measures Wearing a surgical mask caused 0.45mmHg increment in intraocular pressure (p<0.001) regardless of age, gender, the diagnosis of glaucoma, or the sequence of surgical mask-wearing. Men were more vulnerable to the effect of surgical masks on IOP values than women.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2021 Year 03 Month 09 Day
Date of IRB
2021 Year 03 Month 09 Day
Anticipated trial start date
2021 Year 04 Month 12 Day
Last follow-up date
2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 08 Month 03 Day
Last modified on
2022 Year 08 Month 03 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055328

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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