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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034654
Receipt No. R000039509
Scientific Title Effect of massage around eyes on ocular blood flow and vision.
Date of disclosure of the study information 2018/10/26
Last modified on 2019/08/27

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Basic information
Public title Effect of massage around eyes on ocular blood flow and vision.
Acronym Effect of massage around eyes on ocular blood flow and vision.
Scientific Title Effect of massage around eyes on ocular blood flow and vision.
Scientific Title:Acronym Effect of massage around eyes on ocular blood flow and vision.
Region
Japan

Condition
Condition none (healthy subjects)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate effects of four types of massage around eye on ocular blood flow and vision in healthy subjects.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Ocular blood flow obtained by laser speckle flowgraphy, and static vision, dynamic vision and contrast sensitivity, one and two months after the start of daily massage
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Daily five-min Chinese eye exercise for two months. Massage is applied on one eye.
Interventions/Control_2 Daily five-min massage by massage roller for two months. Massage is applied on one eye.
Interventions/Control_3 Daily five-min massage by mechanical eye massage apparatus for two months. Massage is applied on both eyes.
Interventions/Control_4 No massage
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
39 years-old >=
Gender Male and Female
Key inclusion criteria Healthy. No medical treatment nor medication.
Key exclusion criteria Diseases and hypertension. Medical treatment and medication. Hay fever is excluded during its season (mainly spring).
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Naoyuki
Middle name
Last name Hayashi
Organization Tokyo Institute of Technology
Division name Institute for Liberal Arts
Zip code 1528552
Address 2-12-1-W9-1, Ookayama, Meguro, Tokyo , Japan
TEL 03-5734-3434
Email naohayashi@ila.titech.ac.jp

Public contact
Name of contact person
1st name anonymous
Middle name
Last name anonymous
Organization Tokyo Institute of Technology
Division name Research Planning Division
Zip code 1528552
Address 2-12-1, Ookayama, Meguro, Tokyo , Japan
TEL 03-5734-3802
Homepage URL
Email kenkik.som@jim.titech.ac.jp

Sponsor
Institute Tokyo Institute of Technology
Institute
Department

Funding Source
Organization Tokyo Institute of Technology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tokyo Institute of Technology
Address Ookayama 2-12-1-E3-10, Meguro, Tokyo 1528550, Japan
Tel 03-5734-3808
Email hitorinri@jim.titech.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
2018 Year 10 Month 26 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 40
Results
Daily five-min massage around the eyes for two months did not significantly affect visual functions and ocular blood flow. 
Results date posted
2019 Year 08 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 07 Month 01 Day
Date of IRB
2018 Year 08 Month 07 Day
Anticipated trial start date
2019 Year 01 Month 20 Day
Last follow-up date
2019 Year 05 Month 20 Day
Date of closure to data entry
2019 Year 07 Month 10 Day
Date trial data considered complete
2019 Year 07 Month 21 Day
Date analysis concluded
2019 Year 08 Month 26 Day

Other
Other related information

Management information
Registered date
2018 Year 10 Month 26 Day
Last modified on
2019 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039509

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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