UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048558 |
|---|---|
| Receipt number | 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 01:09:59 |
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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
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
sysung52@gmail.com
Sponsor or person
Institute
Kaohsiung Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055328
