UMIN-CTR Clinical Trial

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
Email	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
Email	asaken@kitasato-u.ac.jp

Sponsor
Institute	School of Allied Health Science, Kitasato University
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025973