UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter prospective study on effectiveness of color visual field test
Acronym	Evaluation of effectiveness of color visual field test
Scientific Title	Multicenter prospective study on effectiveness of color visual field test
Scientific Title:Acronym	Evaluation of effectiveness of color visual field test
Region	Japan

Condition
Condition	Healthy patient without ophthalmologic disease, glaucoma, early diabetic retinopathy, branch retinal vein occlusion, central retinal vein occlusion, central serous chorioretinopathy, epiretinal membrane, and macular hole
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	There was no abnormality on visual field text for early glaucoma, but there is change on epiretinal structure. Even when the retinal disease patient with good visual acuity claims difficulty to see, abnormality may not be detected by existing test. Assuming that this may be an abnormality outside the range, visual acuity test using color as high sensitivity subjective test was developed. Goal of this study is to evaluate the effectiveness of the test.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Find the significant difference by comparing the retinal sensitivity between normal group and disease group
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Patient who receive explanation and agreed to participate in this study
Key exclusion criteria	Congenital color vision defect
Target sample size	160

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Sato
Organization	Yuya Sato Eye Clinic
Division name	Yuya Sato Eye Clinic
Zip code	980-0022
Address	1-6-23 Itsutsubashi Aobaku Sendai
TEL	022-227-6752
Email	sato@chukyogroup.jp

Public contact
Name of contact person	1st name Hiroyuki Middle name Last name Sato
Organization	Yuya Sato Eye Clinic
Division name	Yuya Sato Eye Clinic
Zip code	980-0022
Address	1-6-23 Itsutsubashi Aobaku Sendai
TEL	022-227-6752
Homepage URL
Email	sato@chukyogroup.jp

Sponsor
Institute	Yuya Sato Eye Clinic
Institute
Department

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

Other related organizations
Co-sponsor	Chukyo Eye Clinic Vision Research Laboratory JCHO Chukyo Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Chukyo Medical Co., Ltd. REC
Address	12-23, Sanbonmatsu-cho, Atsuta-ku, Nagoya-city, Aichi
Tel	052-884-7976
Email	irb@chukyomedical.co.jp

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 09 Month 25 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	0
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 09 Month 25 Day
Date of IRB	2017 Year 09 Month 22 Day
Anticipated trial start date	2017 Year 09 Month 25 Day
Last follow-up date	2022 Year 03 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Find the significant difference by comparing the retinal sensitivity between normal group and disease group

Management information
Registered date	2017 Year 09 Month 25 Day
Last modified on	2022 Year 03 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033467