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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002208
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002690

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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