UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029280 |
|---|---|
| Receipt number | 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 | 2022/03/29 16:47:30 |
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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 | 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
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
sato@chukyogroup.jp
Sponsor or person
Institute
Yuya Sato Eye Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033467
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
