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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012754
Receipt No. R000014137
Scientific Title Clinical trial of chronically implanted retinal prosthesis by Suprachoroidal-Transretinal Stimulaiton in patient with retinitis pigmentosa
Date of disclosure of the study information 2014/01/04
Last modified on 2018/07/10

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Basic information
Public title Clinical trial of chronically implanted retinal prosthesis by Suprachoroidal-Transretinal Stimulaiton in patient with retinitis pigmentosa
Acronym Clinical trial of chronically implanted retinal prosthesis by Suprachoroidal-Transretinal Stimulaiton
Scientific Title Clinical trial of chronically implanted retinal prosthesis by Suprachoroidal-Transretinal Stimulaiton in patient with retinitis pigmentosa
Scientific Title:Acronym Clinical trial of chronically implanted retinal prosthesis by Suprachoroidal-Transretinal Stimulaiton
Region
Japan

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

Objectives
Narrative objectives1 To investigate safety and efficacy for STS retinal prostheis, we will implant the retinal prostheis to retinitis pigmentosa patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy; comparison of the results of localization test, motion test, grating acuity, and mobility test.

Safety; slit lamp examination, funduscopy and device check
Key secondary outcomes Efficacy; mobility test, questionnaire for quality of vision, PET, and NIRS

Safety; fluorescein angiography, eye-movement test, OCT,and phosphene test in transcorneal-stimulation

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 Implantation of retinal prosthesis
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
40 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients who are diagnosed retinitis pigmentosa by multiple ophthalmologists.

2. Patients whose visual acuity are hand motion, light perception, or no light perception.

3. Patients who do not have any severe disease except from eye diseases.

4. Patients who are able to live independent daily life and walk using a white cane.

5. Patients who can go to the hospital for regular examinations after the surgery.

6. Patient's family members are able to take care of their daily living.

7. The age limits are from 40 to 75 years old.

8. Written informed consent is obtained from the patient.
Key exclusion criteria 1. Patients with glaucoma, optic nerve disease, or retinal disease except from retinitis pigmentosa.


2. Patients with intracranial disease such as cerebral infarction or brain tumor.

3. Patients who are implanted any electrical device such as a cochlear implant or a deep brain stimulation.

4. Patients who are pregnant.

5. Patients with epilepsy.

6. Patients who cannot find phosphenes by electrical stimulation through cornea with less than 1.5 mA

7. Patients who refuse to receive treatment.

8. Patients who are decided by physicians in charge as being inappropriate this clinical trial.
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Fujikado
Organization Osaka University Graduate School of Medicine
Division name Department of Applied Visual Science
Zip code
Address 2-2 Yamadaoka, Suita, Osaka-pref.
TEL 06-6879-3941
Email fujikado@ophthal.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Fujikado
Organization Osaka University Graduate School of Medicine
Division name Department of Applied Visual Science
Zip code
Address 2-2 Yamadaoka, Suita, Osaka-pref.
TEL 06-6879-3941
Homepage URL
Email fujikado@ophthal.med.osaka-u.ac.jp

Sponsor
Institute Department of Applied Visual Science, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2014 Year 01 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

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
2013 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2018 Year 07 Month 10 Day
Date analysis concluded
2018 Year 07 Month 10 Day

Other
Other related information

Management information
Registered date
2014 Year 01 Month 04 Day
Last modified on
2018 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014137

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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