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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000021889
Receipt No. R000025238
Scientific Title Voluntary clinical trials to examine the safety and efficacy of transdermal electrical stimulation intended for non-arteritic ischemic optic neuropathy
Date of disclosure of the study information 2016/04/12
Last modified on 2017/07/11

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Basic information
Public title Voluntary clinical trials to examine the safety and efficacy of transdermal electrical stimulation intended for non-arteritic ischemic optic neuropathy
Acronym Transdermal electrical stimulation intended for NAION
Scientific Title Voluntary clinical trials to examine the safety and efficacy of transdermal electrical stimulation intended for non-arteritic ischemic optic neuropathy
Scientific Title:Acronym Transdermal electrical stimulation intended for NAION
Region
Japan

Condition
Condition non-arteritic ischemic optic neuropathy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the safety and efficacy of transdermal electrical stimulation treatment with the skin electrode for non arteritic ischemic optic neuropathy patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Safety (adverse events such as decrease of visual function, skin disorders)
Evaluated at the time of 1 hour, 1 week, 2 weeks, and 4 weeks after the end of the treatment
Key secondary outcomes 1:visual acuity
2:Retinal sensitivity
3:electroretinogram
4:Optical coherence tomography
5:Visual field
6:Quality of vision
7:Critical fusion frequency

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 Total of three times through the skin electrical stimulation to every two weeks
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 Non-arteritic ischemic optic neuropathy patients
Age: 50 years of age or older, less than 80 years of age (at the time of obtaining informed consent)
Vision: Hand motion or more, and 0.5 of decimal visual acuity or less
Patients after receiving a sufficient explanation Upon participation in the present study, after an adequate understanding, the document agreed by the free will of the patient himself was obtained
Key exclusion criteria Arteritic ischemic optic neuropathy patients
Patients with vitreous macular traction syndrome, macular edema, macular lesions such as epiretinal mebrane
Patients admitted the loss of vision caused by eye diseases other than ischemic optic neuropathy, the study director (sharing) doctor was ineligible
Patients retinal vein occlusion, have merged the retinal artery occlusion
Patients who are complicated by diabetic retinopathy
Patients who are complicated by glaucoma
History of optic nerve diseases other than ischemic optic neuropathy
Inflammation of the external eye, the merger of the infection or severe dry eye
Patients who use oral of Methycobal within 31 days, oral circulatory disorder improving drugs, oral platelet aggregation inhibitor, the drug or the like of oral corticosteroids (eye drops are excluded)
Patients who underwent intravenous administration of prostaglandin E formulation within 31 days
Patients who underwent a stellate ganglion block within 31 days
Patients with unoprostone eye drops within 31 days
Patients within three months a history of eye surgery
Drug that you plan to use during the test period (ophthalmic anesthetic, mydriatics, etc.) with respect to, history of drug allergy
Patients likely to have been pregnant or pregnant. Patients during breast-feeding. Patients who wish to become pregnant during the study period.
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayuki Baba
Organization Chiba university
Division name Department of Ophthalmology
Zip code
Address 1-8-1 Inohana Chuo-ku Chiba-shi Chiba
TEL 043-222-7171
Email babatakayuki@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Gen Miura
Organization Chiba university
Division name Department of Ophthalmology
Zip code
Address 1-8-1 Inohana Chuo-ku Chiba-shi Chiba
TEL 043-222-7171
Homepage URL
Email gmiura2@chiba-u.jp

Sponsor
Institute Chiba university
Department of Ophthalmology
Institute
Department

Funding Source
Organization Chiba university
Organization
Division
Category of Funding Organization Other
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 YES
Study ID_1 UH2016010C
Org. issuing International ID_1 ACReSS
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 千葉大学病院(千葉県)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 12 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 Terminated
Date of protocol fixation
2015 Year 11 Month 16 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 12 Day
Last modified on
2017 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025238

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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