UMIN-CTR Clinical Trial

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

non-arteritic ischemic optic neuropathy

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Chiba university
Department of Ophthalmology

Institute

Department

Personal name

Organization

Chiba university

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

千葉大学病院（千葉県）

Date of disclosure of the study information

2016

Year

04

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

04

Month

12

Day

Last modified on

2017

Year

07

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025238