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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017068
Receipt No. R000019800
Scientific Title Corneal biomechanics in patients with eye dieses
Date of disclosure of the study information 2015/04/09
Last modified on 2016/02/29

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Basic information
Public title Corneal biomechanics in patients with eye dieses
Acronym Corneal biomechanics in patients with eye dieses
Scientific Title Corneal biomechanics in patients with eye dieses
Scientific Title:Acronym Corneal biomechanics in patients with eye dieses
Region
Japan

Condition
Condition Eye disease
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate disease-specific Corneal biomechanics
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To elucidate disease-specific Corneal biomechanics
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 Subjects undergo ophthalmic examinations and analysis of corneal biomechanical proprieties
Key exclusion criteria The presence of a corneal wound or scarification, which could affect the measurements
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiaki Kiuchi
Organization Hiroshima university
Division name Department of ophthalmology and visual science institute of biomedical & health sciences
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-5555(5247)
Email ykiuchi@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitaka Nakao
Organization Hiroshima university
Division name Department of ophthalmology and visual science institute of biomedical & health sciences
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-5555(5247)
Homepage URL
Email nakao@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima university graduate school of biomedical sciences department of ophthalmology and visual science
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Ophthalmology, Tsukazaki Hospital.
Department of Ophthalmology, The University of Tokyo.
Universitas Islam Negeri Alauddin Makassar
Department of Ophthalmology,Kagoshima University Graduate School of Medical and Dental Sciences
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 広島大学病院(広島県)
ツカザキ病院(兵庫県)
東京大学大学院 眼科(東京都)
鹿児島大学病院 眼科(鹿児島県)

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 09 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
ongoing
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 Open public recruiting
Date of protocol fixation
2014 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2014 Year 02 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 prospective study

Management information
Registered date
2015 Year 04 Month 07 Day
Last modified on
2016 Year 02 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019800

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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