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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029391
Receipt No. R000033590
Scientific Title Investigation of the clinical usefulness of next generation optical coherence tomography
Date of disclosure of the study information 2017/10/03
Last modified on 2017/10/02

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Basic information
Public title Investigation of the clinical usefulness of next generation optical coherence tomography
Acronym clinical usefulness of next generation OCT
Scientific Title Investigation of the clinical usefulness of next generation optical coherence tomography
Scientific Title:Acronym clinical usefulness of next generation OCT
Region
Japan

Condition
Condition retinal diseases
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A new prototype of a wide-field OCT system can take images with the extended scan area and depth compared with commercially available instruments.
In the present study, we obtain the wide-field OCT images of retinal diseases mainly including the pathologic myopia, and lead to the practical application.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes clarify the usefulness of the prototype OCT
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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 application of prototype wide-field OCT
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
6 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who visited the clinic of ophthalmology and agreed to participate the study
Key exclusion criteria poor images because of the poor fixation or dense cataracts
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kyoko Ohno-Matsui
Organization Tokyo Medical and Dental University hospital
Division name Ophthalmology
Zip code
Address Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL 03-3813-6111
Email k.ohno.oph@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kyoko Ohno-Matsui
Organization Tokyo Medical and Dental University hospital
Division name Ophthalmology
Zip code
Address Yushima 1-5-45, Bunkyo-ku, Tokyo
TEL 03-3813-6111
Homepage URL
Email k.ohno.oph@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University hospital
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University hospital
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 03 Day

Related information
URL releasing protocol
Publication of results Partially 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 Open public recruiting
Date of protocol fixation
2015 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 02 Day
Last modified on
2017 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033590

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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