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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034296
Receipt No. R000038233
Scientific Title The correlation between cognitive function and refractive error
Date of disclosure of the study information 2018/09/28
Last modified on 2018/09/27

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Basic information
Public title The correlation between cognitive function and refractive error
Acronym The correlation between cognitive function and refractive error
Scientific Title The correlation between cognitive function and refractive error
Scientific Title:Acronym The correlation between cognitive function and refractive error
Region
Japan

Condition
Condition cognitive function, refractive error
Classification by specialty
Neurology Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the correlation between cognitive function and refractive error.
Basic objectives2 Others
Basic objectives -Others relevance
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The presence of mild cognitive impairment (MCI)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 cognitive function tests and a questionnaire
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
60 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients of 60 years old and above who agree to participate in this study are included.
Key exclusion criteria Patients whose refractometry can not be measured and patients who can not undergo the tests of cognitive function are excluded.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akitaka Tsujikawa
Organization Kyoto University
Division name Department of ophthalomolgy
Zip code
Address 54 Shougoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL 0757513248
Email tujikawa@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name consultation office
Organization Kyoto University Hospital
Division name consultation office
Zip code
Address 54 Shougoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL 0757514748
Homepage URL
Email ctsodan@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of ophthalmology, Kyoto University Hospital
Institute
Department

Funding Source
Organization Kyoto University, department of ophthalmology
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
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
2018 Year 09 Month 28 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 Preinitiation
Date of protocol fixation
2018 Year 08 Month 08 Day
Date of IRB
Anticipated trial start date
2018 Year 10 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
2018 Year 09 Month 27 Day
Last modified on
2018 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038233

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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