UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005050 |
|---|---|
| Receipt number | 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 20:12:04 |
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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
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
takeshi.morimoto@ophthal.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka university graduate school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004681
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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