UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of steady state visual evoked potential, SSVEP on Irlen Syndrome
Acronym	SSVEP
Scientific Title	Analysis of steady state visual evoked potential, SSVEP on Irlen Syndrome
Scientific Title:Acronym	SSVEP
Region	Japan

Condition
Condition	Eye disease with Irlen syndrome and photophobia
Classification by specialty	Ophthalmology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	By observing the electroencephalographic response using SSVEP on Irlen syndrome which was not abnormal in general eye examination, effectiveness of objective screening method toward Irlen syndrom's distinctive photalgia was verified.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual acuity, intraocular pressure, fundus, OCT, visual field (Humphrey 30-2), SPP3, BUT, Schirmer test
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Visual acuity, intraocular pressure, fundus, OCT, visual field (Humphrey 30-2), SPP3, BUT, Schirmer test
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Person with Irlen syndrome Healthy person without eye disease Person with either dry-eye, or glaucoma
Key exclusion criteria	Person who had epilepsia Person who got sick while watching flickering scene on the television
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Toshio Middle name Last name Mori
Organization	Iida Municipal Hospital
Division name	Ophthalmology
Zip code	395-8502
Address	438 Yawatamachi Iida city, Nagano
TEL	0265-21-1255
Email	mori@chukyogroup.jp

Public contact
Name of contact person	1st name Yoshiki Middle name Last name Tanaka
Organization	Chukyo Eye Clinic
Division name	Vision Research Laboratory
Zip code	456-0032
Address	12-23 Sanbonmatsu Atsuta-ku, Nagoya
TEL	052-883-1543
Homepage URL
Email	ytanaka@chukyomedical.co.jp

Sponsor
Institute	Chukyo Eye Clinic
Institute
Department

Funding Source
Organization	Chukyo Medical Co., Ltd.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
Email	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 08 Month 28 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 08 Month 28 Day
Date of IRB	2017 Year 07 Month 18 Day
Anticipated trial start date	2017 Year 08 Month 28 Day
Last follow-up date	2022 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 08 Month 28 Day
Last modified on	2022 Year 03 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033022