UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017580
Receipt number R000020375
Scientific Title Investigate and developt of non-invasive fundus oximetry
Date of disclosure of the study information 2015/05/15
Last modified on 2015/05/15 10:59:31

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Basic information

Public title

Investigate and developt of non-invasive fundus oximetry

Acronym

Investigation of fundus oximetry

Scientific Title

Investigate and developt of non-invasive fundus oximetry

Scientific Title:Acronym

Investigation of fundus oximetry

Region

Japan


Condition

Condition

Fundus deseases

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigate and develop of novel fundus oximetry.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Fundus images.

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

10 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Persons with provision of written informed consent regarding study participation, data collection of fundus images, data analysis of fundus images, collection of medical records at patients examinations and analysis of medical records at patients examinations.

Key exclusion criteria

1:Cases of that were unable to take fundus images.
2:Cases of that were considered excluded by ophthalmologist.

Target sample size

180


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Enaida

Organization

Saga university of faculty of medicine

Division name

Department of ophthalmology

Zip code


Address

5-1-1 Nabeshima, Saga 849-8501, Japan

TEL

0952-34-2384

Email

enaida@cc.saga-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinichiro Ishikawa

Organization

Saga university of faculty of medicine

Division name

Department of ophthalmology

Zip code


Address

-1-1 Nabeshima, Saga 849-8501, Japan

TEL

0952-34-2384

Homepage URL


Email

c1441@cc.saga-u.ac.jp


Sponsor or person

Institute

Saga university

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology.

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kyusyu 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



Other administrative information

Date of disclosure of the study information

2015 Year 05 Month 15 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

Open public recruiting

Date of protocol fixation

2014 Year 05 Month 12 Day

Date of IRB


Anticipated trial start date

2014 Year 05 Month 21 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Prospective study. Random sampling.


Management information

Registered date

2015 Year 05 Month 15 Day

Last modified on

2015 Year 05 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020375


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name