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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017845
Receipt No. 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

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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
Email 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
Email ozawa@a5.keio.jp

Sponsor
Institute Keio University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020679

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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