UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024149
Receipt number R000027356
Scientific Title The influence of posture change on ocular flood flow and intraocular pressure in normal subjects.
Date of disclosure of the study information 2016/10/31
Last modified on 2020/09/28 13:58:49

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The influence of posture change on ocular flood flow and intraocular pressure in normal subjects.

Acronym

The influence of posture change on ocular blood flow and intraocular pressure in normal subjects.

Scientific Title

The influence of posture change on ocular flood flow and intraocular pressure in normal subjects.

Scientific Title:Acronym

The influence of posture change on ocular blood flow and intraocular pressure in normal subjects.

Region

Japan


Condition

Condition

healthy volunteer

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the influence of posture change on ocular blood flow and intraocular pressure using laser speckle flowgraphy.

Basic objectives2

Others

Basic objectives -Others

To investigate the association between the change of ocular blood flow and the measurements of optical coherence tomography (OCT).

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Assessment of mean blur rate measured by laser speckle flowgraphy before and after posture change.

Key secondary outcomes

Correlation between mean blur rate, measurements of OCT and IOP.


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

Device,equipment

Interventions/Control_1

Assessment of mean blur rate measured by laser speckle flowgraphy in both a sitting and a supine position.

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

30 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Subjects who met all of the following inclusion criteria are included:normal findings on slit-lamp biomicroscopy and funduscopic examination,intraocular pressure less tthan 21mmHg,best-corrected visual acuity of at least 15/25,spherical refractie errors between -6.00 and +6.00 diopters,and arefractive cylindrical error within +/-2.00D and axial lengths less than 26mm.

Key exclusion criteria

Subjects who aren't satisfied with inclusion criteria.Subjects who have a history of intraocular surgery except for cataract.
Subjects who have a clinically significant retina-choroidal disease,vitreous disease,or corneal disease.Subjects who have high systolic blood pressure over 150mmHg or high diastolic pressure over 90mmHg at rest.Subjects who are taking Ca blocker,or alpha-1 blocker,or beta-1 blocker,or Sildenafil.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Kyoko
Middle name
Last name Ishida

Organization

Department of Ophthalmology, Toho University Ohashi Medical Center.

Division name

Department of Ophthalmology

Zip code

1538515

Address

Ohashi, 2-17-6, Meguro-ku, Tokyo, Japan

TEL

03-3468-1251

Email

kyoko.ish@gmail.com


Public contact

Name of contact person

1st name Hakuei
Middle name
Last name Honda

Organization

Department of Ophthalmology, Toho University Ohashi Medical Center.

Division name

Department of Ophthalmology

Zip code

1538515

Address

Ohashi, 2-17-6, Meguro-ku, Tokyo, Japan

TEL

03-3468-1251

Homepage URL


Email

89ahonda@gmail.com


Sponsor or person

Institute

Department of Ophthalmology, Toho University Ohashi Medical Center.

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics committee of Toho University Ohashi

Address

Ohashi, 2-17-6, Meguro-ku, Tokyo, Japan

Tel

03-3468-1251

Email

secretary@oha.toho-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

2016 Year 10 Month 31 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

2016 Year 08 Month 24 Day

Date of IRB

2016 Year 08 Month 24 Day

Anticipated trial start date

2016 Year 09 Month 24 Day

Last follow-up date

2019 Year 09 Month 23 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 09 Month 24 Day

Last modified on

2020 Year 09 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027356


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name