UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005049 |
|---|---|
| Receipt number | R000004487 |
| Scientific Title | transcorneal electrical stimulation therapy for optic neuropathies and retinal degenerative diseases |
| Date of disclosure of the study information | 2011/02/08 |
| Last modified on | 2015/08/31 20:11:24 |
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Basic information
Public title
transcorneal electrical stimulation therapy for optic neuropathies and retinal degenerative diseases
Acronym
TES for optic neuropathies and retinal degenerative diseases
Scientific Title
transcorneal electrical stimulation therapy for optic neuropathies and retinal degenerative diseases
Scientific Title:Acronym
TES for optic neuropathies and retinal degenerative diseases
Region
| Japan |
Condition
Condition
optic neuropathies and retinal degenerative diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the safety and efficacy of TES for optic neuropathies and retinal diseases
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
enhenched visual acuity, enhanced visual field and safety 1, 3, 6, 12 months after treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
1mA-20Hz-30min
Interventions/Control_2
0.3mA-20Hz-30min
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
TON, NAION, Glaucoma, IOA, retinitis pigmentosa
Visual acuity 0.1 to 0.7
no systematic diseases
accepted informed consent
age 18 to 80 years old
Key exclusion criteria
other ocular diseases
brain tumor, brain attack
AION
cochlear implants
pregnancy
Target sample size
540
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
06-6879-3941
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
G4 2-2 yamadaoka suita osaka Japan
TEL
06-6879-3941
Homepage URL
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 | 01 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 11 | Month | 01 | Day |
Other
Other related information
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=R000004487
