UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of a new colour-vision test chart
Title of the study (Brief title)	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	Aya Ohira
Organization	National Center for Global Health and Medicine
Division name	Ophthalmology department
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	Aya Ohira
Organization	National Center for Global Health and Medicine
Division name	Ophthalmology department
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

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 10 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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