UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028959
Receipt number R000029046
Scientific Title Assessment of choroidal structure and circulation in normal eyes during the water drinking test
Date of disclosure of the study information 2017/09/02
Last modified on 2017/09/01 16:05:30

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Basic information

Public title

Assessment of choroidal structure and circulation in normal eyes during the water drinking test

Acronym

Choroidal structure and circulation during the water drinking test

Scientific Title

Assessment of choroidal structure and circulation in normal eyes during the water drinking test

Scientific Title:Acronym

Choroidal structure and circulation during the water drinking test

Region

Japan


Condition

Condition

retinal and choroidal disease

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To obtain information on the structure and blood flow of the choroid

Basic objectives2

Others

Basic objectives -Others

Water drinking test-induced changes in the choroidal structure on EDI-OCT images and choroidal blood flow evaluated with laser speckle flowgraphy(LSFG)

Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Choroidal structure on EDI-OCT images with image processing

Key secondary outcomes

Choroidal blood flow evaluated with Laser speckle flow graphy


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

Prevention

Type of intervention

Other

Interventions/Control_1

Water drinking test

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

60 years-old >=

Gender

Male and Female

Key inclusion criteria

Non-smoking individuals with no ophthalmic or systemic disorders.

Key exclusion criteria

an age of <18 years or >60 years.
high myopia defined as a refractive error (spherical equivalent) greater than -6.0 diopters or an axial length of >26.5 mm, poor quality EDI-OCT image defined as an image index of <30, abnormal EDI-OCT findings, and previous ocular surgeries.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Daisuke Nagasato

Organization

Saneikai Tsukazaki Hospital

Division name

Ophthalmology

Zip code


Address

68-1 Aboshikuwaku Himeji City Hyogo

TEL

079-282-8555

Email

d.nagasato@tsukazaki-eye.net


Public contact

Name of contact person

1st name
Middle name
Last name Daisuke Nagasato

Organization

Saneikai Tsukazaki Hospital

Division name

Ophthalmology

Zip code


Address

68-1 Aboshikuwaku Himeji City Hyogo

TEL

079-282-8555

Homepage URL


Email

d.nagasato@tsukazaki-eye.net


Sponsor or person

Institute

Saneikai Tsukazaki Hospital
Ophthalmology

Institute

Department

Personal name



Funding Source

Organization

no

Organization

Division

Category of Funding Organization

Other

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 09 Month 02 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

No longer recruiting

Date of protocol fixation

2016 Year 12 Month 09 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 20 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 09 Month 01 Day

Last modified on

2017 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=R000029046


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name