UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031476 |
|---|---|
| Receipt number | R000035930 |
| Scientific Title | Image evaluation of Mirante (SR002) by fundus examination of retinal diseases |
| Date of disclosure of the study information | 2018/02/26 |
| Last modified on | 2019/02/27 16:20:13 |
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Basic information
Public title
Image evaluation of Mirante (SR002) by fundus examination of retinal diseases
Acronym
Image evaluation study of Mirante
Scientific Title
Image evaluation of Mirante (SR002) by fundus examination of retinal diseases
Scientific Title:Acronym
Image evaluation study of Mirante
Region
| Japan |
Condition
Condition
Retinal Diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the performance of Mirante by evaluating the images.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of SLO images
Key secondary outcomes
Evaluation of OCT images
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Images are taken by Mirante
Duration: 1 day
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Subjects greater than or equal to 20 years of age,
2) Subjects who have a retinal diagnosis including but not limited to:
- Age related macular degeneration (AMD)
- Diabetic retinopathy (DR)
- Retinal vein occlusion (RVO)
- Central serous chorioretinopathy (CSC)
- Polypoidal choroidal vasculopathy (PCV)
3) Subjects who sign an informed consent form to participate in the study.
Key exclusion criteria
1) Patients with involuntary eye movement during fixation that may affect evaluation of SLO / OCT images
2) Patients with corneal opacity that may affect evaluation of SLO / OCT images
3) Patients who are judged inappropriate to participate in the study by the investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shozo Sonoda |
Organization
Kagoshima Sonoda Eye Clinic & Plastic Surgery
Division name
Eye Clinic
Zip code
Address
29-4 Chuo-cho, Kagoshima
TEL
099-210-5311
shou@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shozo Sonoda |
Organization
Kagoshima Sonoda Eye Clinic & Plastic Surgery
Division name
Eye Clinic
Zip code
Address
29-4 Chuo-cho, Kagoshima
TEL
099-210-5311
Homepage URL
shou@m3.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima Sonoda Eye Clinic & Plastic Surgery
Institute
Department
Personal name
Funding Source
Organization
NIDEK CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
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
医療法人 明星会 鹿児島園田眼科 形成外科 (鹿児島県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2018 | Year | 02 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 28 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 26 | Day |
Last modified on
| 2019 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035930
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
