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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026283
Receipt No. R000030024
Scientific Title A Project for the Determination of Average Biometric Values of Japanese Eyes.
Date of disclosure of the study information 2017/02/23
Last modified on 2019/08/27

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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 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
20 years-old <=
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
Institute Osaka university
Institute
Department

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
2017 Year 02 Month 23 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 10 Month 25 Day
Date of IRB
2017 Year 03 Month 01 Day
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The test that will be performed are the uncorrected and corrected distance visual acuity, ocular refraction, anterior segment biometry, corneal topography, ocular aberrations, axial length.

Management information
Registered date
2017 Year 02 Month 23 Day
Last modified on
2019 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030024

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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