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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036927
Receipt No. R000042078
Scientific Title Research in contrast sensitivity function test by Accu-pad
Date of disclosure of the study information 2019/06/03
Last modified on 2019/06/03

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Basic information
Public title Research in contrast sensitivity function test by Accu-pad
Acronym Research in contrast sensitivity function test by Accu-pad
Scientific Title Research in contrast sensitivity function test by Accu-pad
Scientific Title:Acronym Research in contrast sensitivity function test by Accu-pad
Region
Japan

Condition
Condition 1.VA of 0.01 logMAR or better and have no history ocular disease other than refractive error
2.Planning cataract surgery have another history ocular disease
3.Had refractive surgery
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy of contrast sensitivity function test by Accu-pad
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Contrast sensitivity function
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
Device,equipment
Interventions/Control_1 We measure contrast sensitivity by Accu-pad
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.VA of 0.01 logMAR or better and have no history ocular disease other than refractive error
2.Planning cataract surgery have another history ocular disease
3.Had refractive surgery

Key exclusion criteria 1.Have disease other than refractive error and cataract
2.Have surgery other than refractive surgery
3.Have corneal disease or amblyopia
4.Have systemic disease such as a diabetes mellitus,multiple sclerosis
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Wakako
Middle name
Last name Ando
Organization Kitasato University Hospital
Division name Ophthalmology
Zip code 252-0374
Address 1-15-1 Kitasato,Mimami-ku,Sagamihara,Kanagawa
TEL 042-778-8111
Email yui.talahara0422@gmail.com

Public contact
Name of contact person
1st name Yui
Middle name
Last name Takahara
Organization Kitasato University Hospital
Division name Ophthalmology
Zip code 252-0374
Address 1-15-1 Kitasato,Mimami-ku,Sagamihara,Kanagawa
TEL 042-778-8111
Homepage URL
Email yui.talahara0422@gmail.com

Sponsor
Institute Kitasato University Hospital
Institute
Department

Funding Source
Organization None
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 Kitasato University Hospital
Address 1-15-1 Kitasato,Mimami-ku,Sagamihara,Kanagawa
Tel 042-778-8111
Email yui-takahara0422@gmail.com

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
2019 Year 06 Month 03 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
2019 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 03 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 03 Day
Last modified on
2019 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042078

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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