UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022537 |
|---|---|
| Receipt number | R000025973 |
| Scientific Title | Utility of a handheld electroretinography recording device with a disposable skin electrode in healthy subjects |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2019/07/18 11:49:12 |
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Basic information
Public title
Utility of a handheld electroretinography recording device with a disposable skin electrode in healthy subjects
Acronym
Utility of a handheld electroretinography
Scientific Title
Utility of a handheld electroretinography recording device with a disposable skin electrode in healthy subjects
Scientific Title:Acronym
Utility of a handheld electroretinography
Region
| Japan |
Condition
Condition
normal subject
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the reproducibility and inter-examiner consistency in analyzing the retinal parameters using a newly handheld electroretinography recording device with a disposable skin electrode, and their correlation with parameters of the conventional electroretinography was also examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amplitude and latency time of a-wave and b-wave.
Key secondary outcomes
Change values of pupil diameter before and after light stimulus.
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
| 29 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Normal retinal function and structure.
Spherical refraction is within -5 to +5 diopter.
Key exclusion criteria
Participants had unstable fixation with handheld electroretinography.
Handheld electroretinography indicated that the value is impossible to calculate numerically.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Asakawa |
Organization
School of Allied Health Science, Kitasato University
Division name
Department of Orthoptics and Visual Science
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, JAPAN
TEL
0427789667
asaken@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Asakawa |
Organization
School of Allied Health Science, Kitasato University
Division name
Department of Orthoptics and Visual Science
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, JAPAN
TEL
0427789667
Homepage URL
asaken@kitasato-u.ac.jp
Sponsor or person
Institute
School of Allied Health Science, Kitasato University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI, Grant Number 16K21346.
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2016 | Year | 06 | Month | 01 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-Design and Setting: A cross-sectional study at Kitasato university, Department of Orthoptics and Visual Science.
-Recruitment: From June 2016 to March 2017, a recruitment poster placed around campus.
-Measurement outcomes: 1. Amplitude and latency time of a-wave and b-wave. 2. Change values of pupil constriction before and after light stimulus.
Management information
Registered date
| 2016 | Year | 05 | Month | 30 | Day |
Last modified on
| 2019 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025973
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
