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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024851
Receipt No. R000028601
Scientific Title Development of a new colour-vision test chart
Date of disclosure of the study information 2016/11/17
Last modified on 2017/12/14

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Basic information
Public title Development of a new colour-vision test chart
Acronym Novel colour-vision test chart development
Scientific Title Development of a new colour-vision test chart
Scientific Title:Acronym Novel colour-vision test chart development
Region
Japan

Condition
Condition Colour vision abnormality
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop a novel colour-vision test chart which can determine the type and severity of colour vision abnormality.
Basic objectives2 Others
Basic objectives -Others To investigate whether results obtained by the newly developed colour-vision test chart is compatible with test results of 1)Ishihara test plates, 2)Farnsworth Panel D15 test and 3)Lanthony D15 test.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Comparison of test results of the following 4 tests.
1)Ishihara test plates
2)Farnsworth Panel D15 test
3)Lanthony D15 test
4)Novel colour test chart developed in this study
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 1)Ishihara test plates
2)Farnsworth Panel D15 test
3)Lanthony D15 test
4)Novel colour-vision test chart developed in this study
Tests 1) to 3) are performed once each on every subject, test 4) will be performed twice each on every subject.
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 Those diagnosed as having hereditary colour-vision abnormality in the past using currently available colour vision tests.
Key exclusion criteria 1)Those diagnosed with abnormality within the visual system other than colour vision abnormality.
2)Those diagnosed with Diabetes mellitus.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Aya Ohira
Organization National Center for Global Health and Medicine
Division name Ophthalmology department
Zip code
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL +81-3-3202-7181
Email aohira@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Aya Ohira
Organization National Center for Global Health and Medicine
Division name Ophthalmology department
Zip code
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL +81-3-3202-7181
Homepage URL
Email aohira@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Ophthalmology department
Institute
Department

Funding Source
Organization System Research & Development Center,
Ricoh Institute of Information and Communication Technology,
RICOH COMPANY, LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Kanagawa University
Name of secondary funder(s) None

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 国立研究開発法人国立国際医療研究センター(東京都)/
National Center for Global Health and Medicine(Tokyo)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 17 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 Terminated
Date of protocol fixation
2016 Year 10 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 03 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
2016 Year 11 Month 15 Day
Last modified on
2017 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028601

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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