UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034296 |
|---|---|
| Receipt number | 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 18:35:36 |
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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
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
ctsodan@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of ophthalmology, Kyoto University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038233
