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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005050
Receipt No. R000004681
Scientific Title Evaluation of residual inner retinal function by using transcorneal electrical stimulation in patients with hiredity retinal degenerative diseases
Date of disclosure of the study information 2011/02/08
Last modified on 2015/08/31

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Basic information
Public title Evaluation of residual inner retinal function by using transcorneal electrical stimulation in patients with hiredity retinal degenerative diseases
Acronym Evaluation of residual retinal function by using TES in patients with retinal degeneration
Scientific Title Evaluation of residual inner retinal function by using transcorneal electrical stimulation in patients with hiredity retinal degenerative diseases
Scientific Title:Acronym Evaluation of residual retinal function by using TES in patients with retinal degeneration
Region
Japan

Condition
Condition hiredity retinal degenarative disease
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the residual inner retinal function by using TES in patients with retinal degeneration and to select patients for the implantation of retinal prosthesis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes visual acuity, visual field, duration of disease, dulation of lower vision
Key secondary outcomes

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

Not applicable
Gender Male and Female
Key inclusion criteria retinitis pigmentosa
candidate for retinal prosthesis
no systemic diseases
over 20 years old


Key exclusion criteria other ocular diseases
chochlear implants
pregnancy
epilepsy
Target sample size 100

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 G4 2-2 yamadaoka Suita Osaka Japan
TEL 0668793941
Email fujikado@ophthal.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Morimoto
Organization Osaka university graduate school of medicine
Division name department of applied visual science
Zip code
Address 2-2 yamadaoka Suita Osaka Japan
TEL 0668793941
Homepage URL
Email takeshi.morimoto@ophthal.med.osaka-u.ac.jp

Sponsor
Institute Osaka university graduate school of medicine
Institute
Department

Funding Source
Organization MHLW Japan
Organization
Division
Category of Funding Organization
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
2011 Year 02 Month 08 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
2011 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
2015 Year 08 Month 31 Day
Date of closure to data entry
2015 Year 08 Month 31 Day
Date trial data considered complete
2015 Year 08 Month 31 Day
Date analysis concluded
2015 Year 12 Month 01 Day

Other
Other related information prospective study relationship between the results of TES and STS

Management information
Registered date
2011 Year 02 Month 08 Day
Last modified on
2015 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004681

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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