UMIN-CTR Clinical Trial

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
Institute	Chiba university
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040991