UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial of chronically implanted retinal prosthesis by Suprachoroidal-Transretinal Stimulaiton in patient with retinitis pigmentosa
Title of the study (Brief title)	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	Takashi Fujikado
Organization	Osaka University Graduate School of Medicine
Division name	Department of Applied Visual Science
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	Takashi Fujikado
Organization	Osaka University Graduate School of Medicine
Division name	Department of Applied Visual Science
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000014137