UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039650
Receipt number R000045224
Scientific Title Evaluation of normal eyes by multi-contrast optical coherence tomography
Date of disclosure of the study information 2020/03/01
Last modified on 2022/09/01 20:11:27

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Basic information

Public title

Evaluation of normal eyes by multi-contrast optical coherence tomography

Acronym

Evaluation of normal eyes by multi-contrast OCT

Scientific Title

Evaluation of normal eyes by multi-contrast optical coherence tomography

Scientific Title:Acronym

Evaluation of normal eyes by multi-contrast OCT

Region

Japan


Condition

Condition

normal eyes

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the characteristics of images of normal eyes obtained with 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 evaluation of ocular images obtained with 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

Optical 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

Subject with normal eyes without eye disease

Key exclusion criteria

Subjects with eye disease

Target sample size

100


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 Maho

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 or person

Institute

Tokyo Medical University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization

Tokyo Medical University, Instituti onal Review Board

Address

6-1-1 Nishi-shinjuku, Shinjuku, T okyo 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%20normal%20%20T2019-0217.pdf

Publication of results

Partially published


Result

URL related to results and publications

https://www.nature.com/articles/s41598-022-07818-9

Number of participants that the trial has enrolled

50

Results

1.M Miura, et al.Evaluation of choroidal melanin-containing tissue in healthy Japanese subjects by polarization-sensitive optical coherence tomography.Sci Rep 2022,12,4048

2. M Miura, et al. Objective evaluation of choroidal melanin loss in patients with VogtKoyanagiHarada disease using polarization-sensitive optical coherence tomography.Sci Rep 2022,12,3526

Results date posted

2022 Year 03 Month 15 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2022 Year 03 Month 22 Day

Baseline Characteristics


Participant flow


Adverse events

none

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

2021 Year 02 Month 17 Day

Anticipated trial start date

2020 Year 04 Month 01 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

2022 Year 09 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045224


Research Plan
Registered date File name
2021/08/31 研究実施計画書OCT+normal+20210418.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name