UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018080 |
|---|---|
| Receipt number | 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 10:06:55 |
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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
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
hitoshi@kitasato-u.ac.jp
Sponsor or person
Institute
School of Allied Health Science, Kitasato University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020930
