UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017845 |
|---|---|
| Receipt number | R000020679 |
| Scientific Title | Visual function analyses in the healthy people and patients with retinal diseases |
| Date of disclosure of the study information | 2015/06/09 |
| Last modified on | 2017/08/29 16:52:55 |
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Basic information
Public title
Visual function analyses in the healthy people and patients with retinal diseases
Acronym
Visual function reflecting the retinal conditions
Scientific Title
Visual function analyses in the healthy people and patients with retinal diseases
Scientific Title:Acronym
Visual function reflecting the retinal conditions
Region
| Japan |
Condition
Condition
healthy people and patients with retinal diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using EvokeDx, which requires less time and detects fine changes, visual function in the healthy people and patients with retinal diseases are measured.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual function measured by EvokeDx
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy people with no retinal diseases and patients with retinal diseases
Key exclusion criteria
Those who cannot keep quiet to undergo the exmams
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoko Ozawa |
Organization
Keio University
Division name
School of Medicine, Department of Ophthalmology
Zip code
Address
35 Shinanomachi Shinjukuku Tokyo
TEL
03-3353-1211
ozawa@a5.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Ozawa |
Organization
Keio University
Division name
School of Medicine, Department of Ophthalmology
Zip code
Address
35 Shinanomachi Shinjukuku Tokyo
TEL
03-3353-1211
Homepage URL
ozawa@a5.keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Konan Medical USA
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 09 | Day |
Last modified on
| 2017 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020679
