UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012754 |
|---|---|
| Receipt number | 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 14:23:41 |
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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
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
fujikado@ophthal.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Applied Visual Science, Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014137
