UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028852
Receipt number R000033022
Scientific Title Analysis of steady state visual evoked potential, SSVEP on Irlen Syndrome
Date of disclosure of the study information 2017/08/28
Last modified on 2022/03/01 13:44:54

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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 or person

Institute

Chukyo Eye Clinic

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033022


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name