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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028432
Receipt No. R000032531
Scientific Title Clinical trial of assessmento by transcorneal electrical stimulation test for patient with retinal degeneration
Date of disclosure of the study information 2017/07/28
Last modified on 2019/04/03

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Basic information
Public title Clinical trial of assessmento by transcorneal electrical stimulation test for patient with retinal degeneration
Acronym transcorneal electrical stimulation test
Scientific Title Clinical trial of assessmento by transcorneal electrical stimulation test for patient with retinal degeneration
Scientific Title:Acronym transcorneal electrical stimulation test
Region
Japan

Condition
Condition retinal degeneration
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Consideration for Assessment of function of remaining inner retina
Basic objectives2 Others
Basic objectives -Others Assessment of function of remaining inner retina
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Threshold of transcorneal electrical stimulation
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 Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 day -180 ~ 0: informed consent and patient background
day 0: transcorneal electrical stimulation test
day 30: follow up visit
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
25 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.retinitis pigmentosa
2.hand motion, light perception, or no light perception.
3.loss of ERG potential
Key exclusion criteria 1.other ocular diseases
2.retinal tumor
3.brain tumor, brain attack
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Fujikado
Organization Osaka University Graduate School of Medicine
Division name Department of Applied Visual Science
Zip code
Address 2-2 Yamadaoka, Suita, Osaka-pref.
TEL 06-6879-3941
Email fujikado@ophthal.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Fujikado
Organization Osaka University Graduate School of Medicine
Division name Department of Applied Visual Science
Zip code
Address 2-2 Yamadaoka, Suita, Osaka-pref.
TEL 06-6879-3941
Homepage URL
Email fujikado@ophthal.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization AMED
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
2017 Year 07 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
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 05 Month 30 Day
Date of IRB
2017 Year 04 Month 30 Day
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 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 07 Month 28 Day
Last modified on
2019 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032531

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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