UMIN-CTR Clinical Trial

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