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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039648
Receipt No. R000045221
Scientific Title Evaluation of eye disease with multi-contrast optical coherence tomography
Date of disclosure of the study information 2020/03/01
Last modified on 2021/08/31

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Basic information
Public title Evaluation of eye disease with multi-contrast optical coherence tomography
Acronym Evaluation of eye disease with multi-contrast optical coherence tomography
Scientific Title Evaluation of eye disease with multi-contrast optical coherence tomography
Scientific Title:Acronym Evaluation of eye disease with multi-contrast optical coherence tomography
Region
Japan

Condition
Condition eye disease
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the characteristics of images of eye disease lesions obtained by multi-contrast OCT
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Subjective outcomes with observation of images by multi-contrast 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 Measurement of in vivo human eye with multi-contrast 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with eye disease
a) retinochoroidal disease, b) optic nerve disease, c)glaucoma, d)intraocular inflammatory disease, e)corneal opacity
Key exclusion criteria Patients without confirmation of agreement by themselves
Target sample size 800

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Miura
Organization Tokyo Medical University, Ibaraki Medical Center
Division name Dept. of Ophthalmology
Zip code 3000395
Address 3-20-1 Chuo Ami, Inashiki, Ibaraki, Japan
TEL 0298871161
Email m-miura@tokyo-med.ac.jp

Public contact
Name of contact person
1st name Masahiro
Middle name
Last name Miura
Organization Tokyo Medical University, Ibaraki Medical Center
Division name Dept. of Ophthalmology
Zip code 3000395
Address 3-20-1 Chuo Ami, Inashiki, Ibaraki, Japan
TEL 0298871161
Homepage URL http://www.tokyo-med.ac.jp/iba-eye/IRB_list.html
Email m-miura@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University
Institute
Department

Funding Source
Organization JST
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Faculty of Medicine, University of Tsukuba
Name of secondary funder(s) Topcon Co

IRB Contact (For public release)
Organization Tokyo Medical University, Institutional Review Board
Address 6-1-1 Nishi-shinjuku, Shinjuku, Tokyo 1600023 Japan
Tel 03-3351-6141
Email irb@tokyo-med.ac.jp

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 東京医科大学茨城医療センター

Other administrative information
Date of disclosure of the study information
2020 Year 03 Month 01 Day

Related information
URL releasing protocol http://www.tokyo-med.ac.jp/iba-eye/IRB%20MCOCT%20T2019-0072.pdf
Publication of results Unpublished

Result
URL related to results and publications https://www.nature.com/articles/s41598-021-82563-z
Number of participants that the trial has enrolled 21
Results We evaluated 26 eyes of 21 patients with serous PED. RPE-melanin OCT images were calculated from the multi-contrast OCT dataset and compared with near-infrared autofluorescence images. Development of active RPE lesions in the slope region was correlated with the PED configuration. Multi-contrast OCT is useful for objective evaluation of changes in the RPE in patients with age-related macular degeneration.
Results date posted
2021 Year 08 Month 31 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2021 Year 02 Month 03 Day
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
2020 Year 01 Month 10 Day
Date of IRB
2020 Year 02 Month 17 Day
Anticipated trial start date
2020 Year 03 Month 02 Day
Last follow-up date
2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 02 Month 29 Day
Last modified on
2021 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045221

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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