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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031476
Receipt No. 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

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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
Email 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
Email shou@m3.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima Sonoda Eye Clinic & Plastic Surgery
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035930

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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