UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036220 |
|---|---|
| Receipt number | R000041261 |
| Scientific Title | Safety and effectiveness of transdermal electrical stimulation for non-arteritic anterior ischemic optic neuropathy |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2024/09/16 09:10:46 |
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Basic information
Public title
Safety and effectiveness of transdermal electrical stimulation for non-arteritic anterior ischemic optic neuropathy
Acronym
Safety and effectiveness of transdermal electrical stimulation for non-arteritic anterior ischemic optic neuropathy
Scientific Title
Safety and effectiveness of transdermal electrical stimulation for non-arteritic anterior ischemic optic neuropathy
Scientific Title:Acronym
Safety and effectiveness of transdermal electrical stimulation for non-arteritic anterior ischemic optic neuropathy
Region
| Japan |
Condition
Condition
non-arteritic anterior ischemic optic neuropathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety and efficacy of visual function after treatment with transdermal electrical stimulation using skin electrodes for patients with non-arteritic anterior ischemic optic neuropathy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
logMAR visual acuity
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
retinal electrical stimulation
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Clinically diagnosed with Non-Arteritic Anterior Ischemic Optic Neuropathy and age >20-years and <80-years.
2. Patients who have a definitive diagnosis of Non-Arteritic Anterior Ischemic Optic Neuropathy and have been older than 6 months since their estimated onset.
3. Patients with decimal visual acuity less than 0.7 above hand motion.
4. Patients who have obtained informed consent from the person's free will, after receiving sufficient explanation for participating in this clinical trial.
5. Patients who can visit hospital for 12 weeks every 2 weeks.
Key exclusion criteria
1. Patients with ESR>20 mm/h and CRP>10 mg/L in blood tests.
2. Patients who have been confirmed with nonarteritic ischemic optic neuropathy and who have an eye disease other than ischemic optic neuropathy by contrast-enhanced MRI.
3. Patients who have a history of drug allergy to drugs (mydriatics and anesthetics eye drops) to be used during the trial period.
4. Patients with complications that have a significant affect on visual function.
5. Patients with a history of or complications of malignancy. However, patients who have a history but have not relapsed for more than 5 years can be registered.
6. Patients diagnosed and treated for dementia and mental illness.
7. Patients complicated with poor control diabetes (HbA1c>10.0%).
8. Patients with uncontrollable hypertension systolic>180 mmHg and or diastolic 110 mmHg.
9. Patients with liver / renal dysfunction that falls under any of the following at clinical screening.
AST, ALT; more than 3 times the upper limit of facility standard value
Serum creatinine; more than 1.5 times the upper limit of institutional standard value
10. Patients taking ethambutol hydrochloride and / or amiodarone hydrochloride.
11. Patients who were pregnant, breastfeeding, may be or planned to be pregnant during the trial period.
12. Patients participating in other clinical trials.
13. Patients under investigational responsibility shared doctors judged inappropriate for participation in this trial.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Yamamoto |
Organization
Chiba university
Division name
Department of ophthalmology and visual science
Zip code
2630043
Address
1-8-1 Inohana Chio-ku chiba
TEL
0432227171
gmiura2@chiba-u.jp
Public contact
Name of contact person
| 1st name | Gen |
| Middle name | |
| Last name | Miura |
Organization
Chiba university
Division name
Department of ophthalmology and visual science
Zip code
2630043
Address
1-8-1 Inohana Chuo-ku Chiba
TEL
0432227171
Homepage URL
gmiura2@chiba-u.jp
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
Funding Source
Organization
Chiba university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JP
Other related organizations
Co-sponsor
Nagoya city university
Kobe university
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba university
Address
1-8-1 Inohana Chuo-ku Chiba
Tel
0432227171
gmiura2@chiba-u.jp
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
| 2019 | Year | 04 | Month | 01 | 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
| 2018 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 15 | Day |
Last modified on
| 2024 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041261
