UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014722
Receipt number R000017116
Scientific Title Morphology of retina and choroid
Date of disclosure of the study information 2014/08/01
Last modified on 2020/08/10 08:48:59

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Basic information

Public title

Morphology of retina and choroid

Acronym

Morphology of retina and choroid

Scientific Title

Morphology of retina and choroid

Scientific Title:Acronym

Morphology of retina and choroid

Region

Japan


Condition

Condition

retinal diseases and healthy volunteers

Classification by specialty

Ophthalmology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the analyzers for retinal structures in retinal diseases

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

contrast to noise ratio
standard deviation

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Those eyes with no apparent intraocular lesions. The criteria varies in subgroup analysis.

Key exclusion criteria

Those eyes with no apparent intraocular lesions. The criteria varies in subgroup analysis.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshio Hisatomi

Organization

Kyushu Medical Center

Division name

Ophthalmology

Zip code


Address

1-8-1 Jigyohama, chuo-ku, Fukuoka

TEL

092-852-0700

Email

hisatomi@med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshio Hisatomi

Organization

Kyushu Medical Center

Division name

Ophthalmology

Zip code


Address

1-8-1 Jigyohama, chuo-ku, Fukuoka

TEL

092-852-0700

Homepage URL


Email

hisatomi@med.kyushu-u.ac.jp


Sponsor or person

Institute

Kyushu Medical Center

Institute

Department

Personal name



Funding Source

Organization

Kyushu Medical Center

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kyushu University

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

九州医療センター(福岡県)


Other administrative information

Date of disclosure of the study information

2014 Year 08 Month 01 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

2014 Year 08 Month 27 Day

Date of IRB

2014 Year 08 Month 27 Day

Anticipated trial start date

2014 Year 08 Month 27 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

2018 Year 03 Month 31 Day

Date trial data considered complete

2018 Year 03 Month 31 Day

Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information

To examine the repeatability and reproducibility of the OCT images of choroid and retina after image processing


Management information

Registered date

2014 Year 07 Month 31 Day

Last modified on

2020 Year 08 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017116


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name