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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000021887
Receipt No. R000025232
Scientific Title Voluntary clinical trials to examine the safety and efficacy of transdermal electrical stimulation intended for retinitis pigmentosa
Date of disclosure of the study information 2016/04/12
Last modified on 2017/07/11

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Basic information
Public title Voluntary clinical trials to examine the safety and efficacy of transdermal electrical stimulation intended for retinitis pigmentosa
Acronym Transdermal electrical stimulation intended for retinitis pigmentosa
Scientific Title Voluntary clinical trials to examine the safety and efficacy of transdermal electrical stimulation intended for retinitis pigmentosa
Scientific Title:Acronym Transdermal electrical stimulation intended for retinitis pigmentosa
Region
Japan

Condition
Condition Retinitis Pigmentosa
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 retinitis pigmentosa 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

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 Patients who meet all of the following criteria at least one eye

1)typical retinitis pigmentosa patients (less than 20 years of age or 80 years of age)
2)2 times of reliability that was performed within 31 days (fixation failure rate of less than 20%, the false positive rate of less than 15%, false-negative rate of less than 33%) static perimetry (HFA) 10-2 center four points with the average difference in the retina sensitivity is within 3dB, and also less than 30dB any of the value
3)Patient decimal vision of 0.01-0.4
4)Patients with afferent visual field constriction of 10 degrees or less in the 1 / 4 of the Goldman visual field examination (Gp)
5)Patient HFA10-2 of Mean Deviation (MD) value is less than -15dB
6)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 Patients conflict with one of the following:

1)Patients with vitreous macular traction syndrome, macular edema, epiretinal membrane, macular lesions such as high myopia with posterior staphyloma
2)Patients undergoing eye surgery within three months
3)Patients who use isopropyl unoprostone, calcium antagonist, dark adaptation improving agent within 31 days
4)Patient with a history of drug allergy for mydriatic, such as eye drops anesthetic that we plan to use during the trial period
5)Patients who are complicated by diabetic retinopathy
6)patients with merging inflammation external eye, infections, or severe dry eye
7)Patients likely to have been pregnant or pregnant. Patients during breast-feeding. Patients who wish to become pregnant during the study period
8)Patients with a history of optic nerve disease
9)Patients with merger moderate (grade3 of Emery classification) or more of nuclear cataract, serious affect such pre subcapsular cataract, posterior subcapsular cataract or secondary cataract in vision
Target sample size 6

Research contact person
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

Public contact
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

Sponsor
Institute Chiba university
Department of Ophthalmology
Institute
Department

Funding Source
Organization Chiba university
Department of Ophthalmology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 UH2016012C
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

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 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
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=R000025232

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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