UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036219
Receipt number R000040991
Scientific Title Safety and effectiveness of transdermal electrical stimulation for central retinal artery occlusion
Date of disclosure of the study information 2019/04/01
Last modified on 2022/03/01 12:00:48

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Basic information

Public title

Safety and effectiveness of transdermal electrical stimulation for central retinal artery occlusion

Acronym

Safety and effectiveness of transdermal electrical stimulation for central retinal artery occlusion

Scientific Title

Safety and effectiveness of transdermal electrical stimulation for central retinal artery occlusion

Scientific Title:Acronym

Safety and effectiveness of transdermal electrical stimulation for central retinal artery occlusion

Region

Japan


Condition

Condition

Central retinal artery occlusion

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 central retinal artery occlusion.

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 central retinal artery occlusion and age >20-years and <80-years.
2. Patients who have a definitive diagnosis of central retinal artery occlusion 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 who have a history of drug allergy to drugs (mydriatics and anesthetics eye drops) to be used during the trial period.
2. Patients with complications that have a significant affect on visual function.
3. 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.
4. Patients diagnosed and treated for dementia and mental illness.
5. Patients complicated with poor control diabetes (HbA1c (NGSP)> 10.0%).
6. Patients with uncontrollable hypertension (systolic > 180 mmHg and / or diastolic 110 mmHg).
7. 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
8. Patients taking ethambutol hydrochloride and / or amiodarone hydrochloride.
9. Patients who were pregnant, breastfeeding, may be or planned to be pregnant during the trial period.
10. Patients participating in other clinical trials.
11. 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

260-8677

Address

1-8-1 Inohana Chuo-ku

TEL

043-222-7171

Email

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

260-8677

Address

1-8-1 Inohana Chuo-ku, Chiba

TEL

043-222-7171

Homepage URL


Email

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


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Chiba university

Address

1-8-1 Inohana Chuo-ku

Tel

0432227171

Email

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

2022 Year 03 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040991


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name