UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002208 |
|---|---|
| Receipt number | R000002690 |
| Scientific Title | Subacute clinical trial of a suprachoroidal-transretinal stimulation system |
| Date of disclosure of the study information | 2009/09/01 |
| Last modified on | 2013/01/15 16:14:27 |
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Basic information
Public title
Subacute clinical trial of a suprachoroidal-transretinal stimulation system
Acronym
Clinical trial of an artificial vision system
Scientific Title
Subacute clinical trial of a suprachoroidal-transretinal stimulation system
Scientific Title:Acronym
Clinical trial of an artificial vision system
Region
| Japan |
Condition
Condition
retinitis pigmentosa
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of our artificial vision system in a subacute clinical trial and to determine if the patient could be a candidate for our system.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To determine if the phosphene could be elicited by suprachoroidal-transretinal stimulation in patients with retinitis pigmentosa and to study the complications such as inflammation by using this system.
Key secondary outcomes
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
artificial vision system
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with retinitis pigmentosa whose visual acuity are hand motion, light perception, or no light perception.
Key exclusion criteria
patients whose visual acuity are better than hand motion or who can not find phosphenes by electrical stimulation through cornea.
Target sample size
5
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, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Applied Visual Science
Zip code
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3941
Homepage URL
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Ministry of Education, Culture, Sports, Science and Technology
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
| 2009 | Year | 09 | Month | 01 | 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
We carried out the subacute implantation clinical trial (one month) of the STS artificial retina (9 electrodes) for two patients with advanced RP. There were no side effects such as inflammation both during the implantation and after the removal of the device.
About the functional examination, both patients scored better than chance in the object detection and object discrimination tasks with head scanning. Pt 2 scored 90% better than chance in detecting the direction of motion task, but Pt 1 scored 60%, which was not significantly better than chance.
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
| 2009 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 15 | Day |
Last modified on
| 2013 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002690
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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