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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028190
Receipt No. R000031529
Scientific Title Exploratory trial to examine the safety and effectiveness of transdermal electrical stimulation for retinitis pigmentosa
Date of disclosure of the study information 2017/07/12
Last modified on 2018/12/01

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Basic information
Public title Exploratory trial to examine the safety and effectiveness of transdermal electrical stimulation for retinitis pigmentosa
Acronym Exploratory trial to examine the safety and effectiveness of transdermal electrical stimulation for retinitis pigmentosa
Scientific Title Exploratory trial to examine the safety and effectiveness of transdermal electrical stimulation for retinitis pigmentosa
Scientific Title:Acronym Exploratory trial to examine the safety and effectiveness of transdermal electrical stimulation for retinitis pigmentosa
Region
Japan

Condition
Condition retinitis pigmentosa
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Exploritively verify the safety of transdermal electrical stimulation for retinitis pigmentosa and its effectiveness for visual function after the treatment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes safety
Key secondary outcomes effectiveness

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 transdermal electric 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 A case must satisfying all the following criteria.
Evaluation Eye
(1) Typical Retinal pigmented patients (over 20 years old and under 80 years old)
(2) Static visual field examination (HFA) 10-2 with two reliabilities (less than 20% of fixation defect rate, less than 15% false positive rate, false negative rate less than 33%) executed within 6 months The difference in the average retinal sensitivity at the four central points is within 5 dB and both values are less than 30 dB
(3) Patients with decimal visual acuity of 0.1 to 0.7
(4) Patients presenting afferent stenoses within 10 degrees in 1 / 4 of dynamic visual field examination (Gp)
(5) Patients with Mean Deviation (MD) value of HFA 10-2 <-10 dB
(6) After receiving sufficient explanation for the participation of this trial, patients who gained document consent by the patient's free will with sufficient understanding
(7) Patients who can come to hospital for 3 months every 2 weeks
Key exclusion criteria cases who conflict with any of the following must not include this study.
(1) Patients complicated of macular lesions such as vitreous macular traction syndrome, macular edema, epiretinal membrane, and myopia with posterior staphyloma associated with myopia
(2) Patients undergoing internal eye surgery within 3 months
(3) Patients who changed the dose and usage of isopropyl unoprostone, calcium antagonist, dark adaptation improving drug within 31 days before screening
(4) Patients who have a history of drug allergy to drugs to be used during the trial period (mydriatic drugs, eye drops anesthetics, etc.)
(5) Patients complicated with diabetic retinopathy
(6) Patients who are currently complaining of external eye inflammation, infection, or severe dry eye
(7) Patients who may be pregnant or pregnant. Patient who is breastfeeding. Patients who want pregnancy during the trial period
(8) Patients with a history of optic nerve disease
(9) Evaluation of efficacy nuclear cataract with moderate degree (grade 3 in Emery classification) to the eyes, patients with complication of anterior subcapsular, subcapsular cataract, or late cataract which have a serious effect on vision
(10) Patients whose Mean Deviation (MD) value of HFA 10-2 has deteriorated by 3 dB or more per year
(11) Patients who have not seen any deterioration in visual acuity, OCT findings, dynamic visual field inspection (Gp) findings, and visual field sensitivities at HFA 10-2 in the last 3 years
(12) Patients currently participating in other clinical trials
(13) patients under investigational responsibility (shared) doctors judged inappropriate for participation in this trial
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Gen Miura
Organization Chiba university hospital
Division name Ophthalmology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL 0432227171
Email gmiura2@chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Gen Miura
Organization Chiba university hospital
Division name Ophthalmology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba
TEL 0432227171
Homepage URL
Email gmiura2@chiba-u.jp

Sponsor
Institute Chiba university hospital
Institute
Department

Funding Source
Organization Chiba university hospital
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 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
2017 Year 07 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 Completed
Date of protocol fixation
2017 Year 06 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 18 Day
Last follow-up date
2018 Year 02 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 05 Month 15 Day

Other
Other related information

Management information
Registered date
2017 Year 07 Month 11 Day
Last modified on
2018 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031529

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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