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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029280
Receipt No. R000033467
Scientific Title Multicenter prospective study on effectiveness of color visual field test
Date of disclosure of the study information 2017/09/25
Last modified on 2017/09/25

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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
Middle name
Last name Hiroyuki Sato
Organization Yuya Sato Eye Clinic
Division name Yuya Sato Eye Clinic
Zip code
Address 1-6-23 Itsutsubashi Aobaku Sendai
TEL 022-227-6752
Email sato@chukyogroup.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Sato
Organization Yuya Sato Eye Clinic
Division name Yuya Sato Eye Clinic
Zip code
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
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 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
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 Open public recruiting
Date of protocol fixation
2017 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 25 Day
Last follow-up date
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
2017 Year 09 Month 25 Day


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

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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