UMIN-CTR Clinical Trial

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
Last 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
1st 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