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
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
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
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
