UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028432 |
|---|---|
| Receipt number | 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 12:09:22 |
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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
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
fujikado@ophthal.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032531
