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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026519
Receipt No. R000030250
Scientific Title Comparison of depth perception in monocular and binocular vision
Date of disclosure of the study information 2017/03/15
Last modified on 2017/08/25

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Basic information
Public title Comparison of depth perception in monocular and binocular vision
Acronym Comparison of depth perception in monocular and binocular vision
Scientific Title Comparison of depth perception in monocular and binocular vision
Scientific Title:Acronym Comparison of depth perception in monocular and binocular vision
Region
Japan

Condition
Condition Normal volunteer
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the depth perception in monocular and binocular vision.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The depth perception at various distances.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 #Over 20 years old
#Driver's license holder
#Subject who drive in daily life (at least four time per month)
Key exclusion criteria #The best corrected visual acuity of both eyes is (0.7) or over
#The score of MMSE is less than 24 points (MMSE: Mini-Mental State Examination )
#Abnormal stereovision
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuno Negishi
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 35, Shinanomachi, Shinjuku-ku, Tokyo 1608582, Japan
TEL 03-5363-3821
Email kazunonegishi@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuno Negishi
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 35, Shinanomachi, Shinjuku-ku, Tokyo 1608582, Japan
TEL 03-5363-3821
Homepage URL
Email kazunonegishi@keio.jp

Sponsor
Institute Department of Ophthalmology, Keio University School of Medicine
Institute
Department

Funding Source
Organization Hitachi Automotive Systems, Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Hitachi, Ltd.
Hitachi Automotive Systems, Ltd.
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

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 15 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 Completed
Date of protocol fixation
2017 Year 02 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 16 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information Primary outcomes: The depth perception at various distances.

Management information
Registered date
2017 Year 03 Month 13 Day
Last modified on
2017 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030250

Research Plan
Registered date File name
2017/06/18 単眼視・両眼視における深視力の比較_研究計画書_ver1.2.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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