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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018080
Receipt No. R000020930
Scientific Title A Study on the ophthalmological efficacy of somatosensory input
Date of disclosure of the study information 2015/07/01
Last modified on 2018/07/03

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Basic information
Public title A Study on the ophthalmological efficacy of somatosensory input
Acronym Efficacy test of somatosensory input for visual performance
Scientific Title A Study on the ophthalmological efficacy of somatosensory input
Scientific Title:Acronym Efficacy test of somatosensory input for visual performance
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Ophthalmology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the ophthalmological efficacy of somatosensory input for healthy adult eye area
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cardiac electrogram
Skin temperature
Pupil diameter
Near point of accommodation
Cerebral blood flow
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Apply the somatosensory input for around eye area for 10 minutes once a day
Interventions/Control_2 Apply the placebo input for around eye area for 10 minutes once a day
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
30 years-old >=
Gender Male and Female
Key inclusion criteria Healthy male and female
Key exclusion criteria Subjects with eye diseases and any other diseases which requires treatments
Subjects with medication and eyedrops affecting of pupil
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Ishikawa
Organization Department of Rehabilitation, School of Allied Health Science, Kitasato University
Division name Orthoptics and Visual Science Course
Zip code
Address 1-15-1 Kitasato, Minami-ku, Sagamihara 252-0373, Japan
TEL 042-778-9681
Email hitoshi@kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Ishikawa
Organization Department of Rehabilitation, School of Allied Health Science, Kitasato University
Division name Orthoptics and Visual Science Course
Zip code
Address 1-15-1 Kitasato, Minami-ku, Sagamihara 252-0373, Japan
TEL 042-778-9681
Homepage URL
Email hitoshi@kitasato-u.ac.jp

Sponsor
Institute School of Allied Health Science, Kitasato University
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 北里大学医療衛生学部(神奈川県)
School of Allied Health Science, Kitasato University

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2015 Year 06 Month 23 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 06 Month 25 Day
Last modified on
2018 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020930

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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