UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060869 |
|---|---|
| Receipt number | R000069635 |
| Scientific Title | Evaluation of the alleviating effect of periocular warm compression on visual fatigue |
| Date of disclosure of the study information | 2026/03/09 |
| Last modified on | 2026/03/09 09:43:07 |
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Basic information
Public title
Exploration of the alleviating effect on visual fatigue
Acronym
Investigation of simple methods for alleviating visual fatigue
Scientific Title
Evaluation of the alleviating effect of periocular warm compression on visual fatigue
Scientific Title:Acronym
HEM-VF Study
Region
| Japan |
Condition
Condition
visual fatigue, asthenopia
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of periocular warm compression on visual fatigue induced by a visual task, using subjective symptoms and binocular fusion maintenance (BFM) as an objective indicator. While digital device usage causes widespread visual fatigue, effective alleviation methods and objective evaluation metrics have not yet been established. This study aims to objectively verify the efficacy of periocular warm compression in alleviating fatigue and to evaluate the utility of BFM as a quantitative indicator for visual fatigue recovery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Binocular fusion maintenance (BFM) and subjective symptom questionnaires before and after a visual task of 30 minutes or more, and after a rest period.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants apply a commercially available hot eye mask (Megu Rhythm Eye Mask, Kao Corp., Tokyo, Japan) to the periocular region for 5 minutes following a 30-minute visual task. To ensure the mask is used during its peak temperature period, it is opened 7 minutes before the start of the rest period.
Interventions/Control_2
Participants rest with their eyes closed for 5 minutes following a 30-minute visual task without wearing an eye mask. This condition serves as a control for the effect of visual deprivation.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers
Key exclusion criteria
Participants with manifest strabismus or nystagmus
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Hirota |
Organization
Teikyo University
Division name
Department of Orthoptics, Faculty of Medical Technology
Zip code
1738605
Address
2-11-1 Kaga, Tokyo, Japan
TEL
03-3964-1328
hirota.masakazu.lq@teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Hirota |
Organization
Teikyo University
Division name
Department of Orthoptics, Faculty of Medical Technology
Zip code
1738605
Address
2-11-1 Kaga, Tokyo, Japan
TEL
0339641328
Homepage URL
hirota.masakazu.lq@teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
Teikyo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University Ethical Review Board for Medical and Health Research Involving Human Subjects
Address
2-11-1 Kaga, Tokyo, Japan
Tel
03-3964-7256
turb-office@teikyo-u.ac.jp
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
| 2026 | Year | 03 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | 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
| 2026 | Year | 03 | Month | 09 | Day |
Last modified on
| 2026 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069635
