UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043506
Receipt number R000049679
Scientific Title Comparing ocular blood flow in ocular eye movement using leaser speckle flowgraphy.
Date of disclosure of the study information 2021/03/03
Last modified on 2022/07/06 13:29:04

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Basic information

Public title

Comparing ocular blood flow in ocular eye movement using leaser speckle flowgraphy.

Acronym

Comparing ocular blood flow in ocular eye movement using leaser speckle flowgraphy.

Scientific Title

Comparing ocular blood flow in ocular eye movement using leaser speckle flowgraphy.

Scientific Title:Acronym

Comparing ocular blood flow in ocular eye movement using leaser speckle flowgraphy.

Region

Japan


Condition

Condition

Healthy volunteer

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To measure ocular blood flow in eye movement in healthy volunteer.

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To measure ocular blood flow during eye movement in normal eyes and to compare with previously measured data in glaucoma patients

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Mydriatic (tropicamide 0.4%) eye drops before measurement

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

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

The participant who

- doesn't have ophthalmological diseases that affect blood flow measurement other than refractive error.

- doesn't be diagnosed of cardiovascular disease or diabetes mellitus.

- systolic blood pressure is less 150mmHg and diastolic blood pressure is less 90 mmHg.

- doesn't take drugs that affect blood flow (Ca antagonists, alpha1 and beta1 blockers, PDE5 inhibitors).

- has corrected visual acuity more than 0.8.

- doesn't have refractive error exceeding +/-8D in spherical power or +/-2D in astigmatism.

- doesn't have axial length of exceeding 26.5 mm.

- has intraocular pressure of 21mmHg or less.

- doesn't have history of refractive surgery.

Key exclusion criteria

The participant who

- has ophthalmological diseases that affect blood flow measurement other than refractive error.

- diagnosed of cardiovascular disease or diabetes mellitus.

- systolic blood pressure exceeding 150 mmHg and diastolic blood pressure exceeding 90 mmHg.

- Patients taking drugs that affect blood flow (Ca antagonists, alpha1 and beta1 blockers, PDE5 inhibitors).

- has corrected visual acuity less than 0.8.

- has refractive error exceeding +/-8D in spherical power or +/-2D in astigmatism.

- has axial length exceeding 26.5 mm

- has intraocular pressure of 21 mmHg or more

- has patients with a history of refractive surgery.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Toshiaki
Middle name
Last name Goseki

Organization

Kitasato University School of Medicine

Division name

Department of Ophthalmology

Zip code

2500374

Address

1-15-1, Kitasato, Minami-ku, Sgamihara, Kanagawa

TEL

0427788464

Email

toshiaki.goseki@gmail.com


Public contact

Name of contact person

1st name Kazunoei
Middle name Hirasawa
Last name Hirasawa

Organization

Kitasato University School of Medicine

Division name

Department of Ophthalmology

Zip code

2520374

Address

1-15-1, Kitasato, Minami-ku, Sgamihara, Kanagawa

TEL

0427788464

Homepage URL


Email

hirasawa@kitasato-u.ac.jp


Sponsor or person

Institute

Kitasato University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion Of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Research Ethics Committee of the Kitasato University Hospital

Address

1-15-1, Kitasato, Minami-ku, Sgamihara, Kanagawa

Tel

0427788273

Email

rinrib@med.kitasato-u.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



Other administrative information

Date of disclosure of the study information

2021 Year 03 Month 03 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

2021 Year 01 Month 21 Day

Date of IRB

2021 Year 05 Month 11 Day

Anticipated trial start date

2021 Year 05 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2022 Year 03 Month 31 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 03 Month 03 Day

Last modified on

2022 Year 07 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049679


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name