UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026307
Receipt number R000030212
Scientific Title Evaluation of Eye Disease with Optical Coherence Tomograpy
Date of disclosure of the study information 2017/02/27
Last modified on 2022/03/01 17:38:50

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Basic information

Public title

Evaluation of Eye Disease with Optical Coherence Tomograpy

Acronym

Evaluation of Eye Disease with OCT

Scientific Title

Evaluation of Eye Disease with Optical Coherence Tomograpy

Scientific Title:Acronym

Evaluation of Eye Disease with OCT

Region

Japan


Condition

Condition

Eye Disease

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the usefulness of prototype optical coherence tomography to evaluate eye disease

Basic objectives2

Others

Basic objectives -Others

To evaluate the microstructure in the eye disease using optical coherence tomography

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Microstructure change in molecular level
Ocular blood flow

Key secondary outcomes

Distribution of Melanin
Cicatrization
Distribution of blood flow
Blood flow volume


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Observation of Eye disease with optical coherence tomography

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with eye disease

Key exclusion criteria

Patient who withhold assent for this study

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Masahiro
Middle name
Last name Miura

Organization

Ibaraki Medical Center, Tokyo Medical University

Division name

Department of Ophthalmology

Zip code

3000395

Address

3-20-1 Chuo, Ami, Inashiki, Ibaraki 3000395

TEL

0298871161

Email

m-miura@tokyo-med.ac.jp


Public contact

Name of contact person

1st name Masahiro
Middle name
Last name Miura

Organization

Ibaraki Medical Center, Tokyo Medical University

Division name

Department of Ophthalmology

Zip code

3000395

Address

3-20-1 Chuo, Ami, Inashiki, Ibaraki 3000395

TEL

0298871161

Homepage URL

http://www.tokyo-med.ac.jp/iba-eye/kenkyu.html

Email

m-miura@tokyo-med.ac.jp


Sponsor or person

Institute

Department of Ophthalmology
Tokyo Medical University

Institute

Department

Personal name



Funding Source

Organization

Department of Ophthalmology
Tokyo Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

1)Computational Optics Group, University of Tsukuba, 2) Dept of Ophthalmology, Osaka University Graduate School of Medicine

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board, Tokyo Medical University

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(茨城県)


Other administrative information

Date of disclosure of the study information

2017 Year 02 Month 27 Day


Related information

URL releasing protocol

http://www.tokyo-med.ac.jp/iba-eye/kenkyu.html

Publication of results

Partially published


Result

URL related to results and publications

https://www.nature.com/articles/s41598-017-03529-8

Number of participants that the trial has enrolled

100

Results

We evaluated the usefulness of prototype OCT for uveitis and AMD

Results date posted

2020 Year 02 Month 28 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2017 Year 06 Month 09 Day

Baseline Characteristics

Patients with macular disease.

Participant flow

Recruiting at the department of Ophthalmology, Tokyo Medical University, Ibaraki Medeical Center

Adverse events

None

Outcome measures

Evaluation of retinal images obtained by prototype OCT.

Plan to share IPD

None

IPD sharing Plan description

None


Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 08 Month 15 Day

Date of IRB

2016 Year 08 Month 15 Day

Anticipated trial start date

2016 Year 08 Month 15 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry

2022 Year 02 Month 28 Day

Date trial data considered complete

2022 Year 02 Month 28 Day

Date analysis concluded

2022 Year 02 Month 28 Day


Other

Other related information



Management information

Registered date

2017 Year 02 Month 25 Day

Last modified on

2022 Year 03 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030212


Research Plan
Registered date File name
2017/08/27 研究計画書OCT20170303.docx

Research case data specifications
Registered date File name
2017/08/27 説明文書OCT2017_0207.docx

Research case data
Registered date File name
2017/08/27 umin_data20170828.xlsx