UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024220
Receipt number R000027157
Scientific Title A Project for the Determination of Average Biometric Values of Japanese Eyes.
Date of disclosure of the study information 2016/10/25
Last modified on 2017/02/23 19:54:09

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Basic information

Public title

A Project for the Determination of Average Biometric Values of Japanese Eyes.

Acronym

Project Japan eye model.

Scientific Title

A Project for the Determination of Average Biometric Values of Japanese Eyes.

Scientific Title:Acronym

Project Japan eye model.

Region

Japan


Condition

Condition

Normal Subjects, Ametropia

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to determine the average value of Japanese ocular biometry and to create Japanese eye model.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Visual acuity,l Refractive errors, Ocular aberrations, Axial length, Anterior segment biometry, Corneal topography, and Age.

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

Device,equipment

Interventions/Control_1

Tropicamido and phenylephrine.

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

Japanese with over 20 years old.
Ametropia between -10D and +10D.

Key exclusion criteria

The ophthalmological and/or systemic disease without refractive error and cataract.
Prior surgery.
More than 5 months pregnant.
Refraction lager than +/-10D.

Target sample size

250


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Fujikado

Organization

Osaka university graduate school of medicine

Division name

Department of applied visual science

Zip code


Address

2-2 Yamadaoka, Suita, Osaka

TEL

0668793941

Email

fujikado@ophthal.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masakazu Hirota

Organization

Osaka university graduate school of medicine

Division name

Department of applied visual science

Zip code


Address

2-2 Yamadaoka, Suita, Osaka

TEL

0668793941

Homepage URL


Email

hirota.sensory@gmail.com


Sponsor or person

Institute

Osaka university

Institute

Department

Personal name



Funding Source

Organization

The Japanese Society of Ophthalmological Optics

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

大阪大学、北里大学、慶應義塾大学、順天堂大学、筑波大学


Other administrative information

Date of disclosure of the study information

2016 Year 10 Month 25 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

Terminated

Date of protocol fixation

2016 Year 09 Month 29 Day

Date of IRB


Anticipated trial start date

2017 Year 01 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



Management information

Registered date

2016 Year 09 Month 29 Day

Last modified on

2017 Year 02 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027157


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name