UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Voluntary clinical trials to examine the safety and efficacy of transdermal electrical stimulation intended for non-arteritic ischemic optic neuropathy
Title of the study (Brief title)	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	Takayuki Baba
Organization	Chiba university
Division name	Department of Ophthalmology
Address	1-8-1 Inohana Chuo-ku Chiba-shi Chiba
TEL	043-222-7171
Email	babatakayuki@nifty.com

Public contact
Name of contact person	Gen Miura
Organization	Chiba university
Division name	Department of Ophthalmology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 11 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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