UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024851 |
|---|---|
| Receipt number | 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 11:04:52 |
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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
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
aohira@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Ophthalmology department
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
