UMIN-CTR Clinical Trial

Basic information
Public title	Classification of congenital and acquired color vision defect degree using Panel D-15
Acronym	Classification of congenital and acquired color vision defect degree using Panel D-15
Scientific Title	Classification of congenital and acquired color vision defect degree using Panel D-15
Scientific Title:Acronym	Classification of congenital and acquired color vision defect degree using Panel D-15
Region	Japan

Condition
Condition	congenital and acquired color vision defect
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluating effectiveness of color vision defect degree classification by modified Panel D-15
Basic objectives2	Others
Basic objectives -Others	Evaluating effectiveness of color vision defect degree classification by modified Panel D-15
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison with the following results: 1) Ishihara test chart, color vision test chart 2) Panel D-15 3) Lantern test 4) Anomaloscope 5) Modified D-15
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 chart, color vision test chart 2) Panel D-15 3) Lantern test 4) Anomaloscope 5) Modified D-15 4 of above tests will be conducted once for each test 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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	A subject with congenital and acquired color vision defect. As for acquired color vision defect, cataract, glaucoma, retinal disease, and optic nerve disease are included.
Key exclusion criteria	As for congenital color vision defect, subject without other optic disease and acquired color vision defect. As for acquired color vision defect, subject should not have congenital color vision defect.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuo Ichikawa
Organization	Chukyo Eye Clinic
Division name	Color Vision Research Institute
Zip code
Address	12-23 Sanbonmatsu, Atsuta-ku, Nagoya-shi, Aichi
TEL	052-883-1543
Email	ichikawa@chukyogroup.jp

Public contact
Name of contact person	1st name Middle name Last name Yoshiki Tanaka
Organization	Chukyo Eye Clinic
Division name	Color Vision Research Institute
Zip code
Address	12-23 Sanbonmatsu, Atsuta-ku, Nagoya-shi, Aichi
TEL	052-883-1543
Homepage URL
Email	ytanaka@chukyomedical.co.jp

Sponsor
Institute	Chukyo Eye Clinic Color Vision Research Institute
Institute
Department

Funding Source
Organization	Chukyo Medical Co., Ltd.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 22 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	Completed
Date of protocol fixation	2017 Year 02 Month 20 Day
Date of IRB	2017 Year 02 Month 08 Day
Anticipated trial start date	2017 Year 02 Month 22 Day
Last follow-up date	2019 Year 08 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 02 Month 20 Day
Last modified on	2019 Year 08 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030120