UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030155
Receipt number R000032970
Scientific Title effectiveness of ultra wide field fundus camera (optos Daytona) compared to conventional fundus camera in periodic health checkup
Date of disclosure of the study information 2017/11/29
Last modified on 2017/11/30 20:03:33

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Basic information

Public title

effectiveness of ultra wide field fundus camera (optos Daytona) compared to conventional fundus camera in periodic health checkup

Acronym

effectiveness of ultra wide field fundus camera in periodic health checkup

Scientific Title

effectiveness of ultra wide field fundus camera (optos Daytona) compared to conventional fundus camera in periodic health checkup

Scientific Title:Acronym

effectiveness of ultra wide field fundus camera in periodic health checkup

Region

Japan


Condition

Condition

glaucoma
diabetic retinopathy
retinal detachment
retinal tear
epiretinal membrane
age related macula disease
drusen
macula hole
retinal branch vein occlusion
retinal central vein occlusion

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

comparing an ultra wide field fundus camera(optos Daytona) with a conventional fundus camera in periodic health checkup

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

effectiveness of ultra wide field fundus camera in periodic health checkup

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

people who undergo fundus photography

Key exclusion criteria

nothing

Target sample size

10000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuichiro Ogura

Organization

Nagoya City University Graduated School of Medical Science

Division name

visual science

Zip code


Address

Aichi prefecture Nagoya city Mizuho-ku Mizuho-tyo Kawasumi 1

TEL

052-851-5511

Email

ogura@med.nagoya-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideaki Usui

Organization

Nagoya City University Graduated School of Medical Science

Division name

visual science

Zip code


Address

Aichi prefecture Nagoya city Mizuho-ku Mizuho-tyo Kawasumi 1

TEL

052-851-5511

Homepage URL


Email

hideaki.usui@gmail.com


Sponsor or person

Institute

Nagoya City University Graduated School of Medical Science

Institute

Department

Personal name



Funding Source

Organization

Nagoya City University Graduated School of Medical Science
visual science

Organization

Division

Category of Funding Organization

Profit organization

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 11 Month 29 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

No longer recruiting

Date of protocol fixation

2014 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 04 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

none


Management information

Registered date

2017 Year 11 Month 28 Day

Last modified on

2017 Year 11 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032970


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name