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
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
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
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
