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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036219
Receipt No. 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 2019/03/15

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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
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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 12 Day
Date of IRB
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
2019 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.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


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