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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033672
Receipt No. R000038388
Official scientific title of the study Intercomparison analysis of corneal parameters obtained by various devices having different measuring principles.
Date of disclosure of the study information 2018/08/07
Last modified on 2018/08/07

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Basic information
Official scientific title of the study Intercomparison analysis of corneal parameters obtained by various devices having different measuring principles.
Title of the study (Brief title) Comparison of corneal parameters.
Region
Japan

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

Objectives
Narrative objectives1 To elucidate clinical characteristics of corneal parameters from various devices having different measuring principles.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Agreement among corneal parameters from various devices.
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 proprieties.
Key exclusion criteria Subjects with previous intraocular surgery.
Target sample size 228

Research contact person
Name of lead principal investigator Yugo Kimura
Organization Kimura eye and internal medicine hospital
Division name Department of ophthalmology
Address 3-15 Takaramachi, Kure, Hiroshima
TEL 0823225544
Email ky.kimuraeye@gmail.com

Public contact
Name of contact person Yoshitaka Nakao
Organization Kimura eye and internal medicine hospital
Division name Department of ophthalmology
Address 3-15 Takaramachi, Kure, Hiroshima
TEL 0823225544
Homepage URL
Email Yoshitaka.nakao@kimura-eye.or.jp

Sponsor
Institute Kimura eye and internal medicine hospital
Institute
Department

Funding Source
Organization Kimura eye and internal medicine hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 08 Month 07 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 06 Month 23 Day
Anticipated trial start date
2018 Year 08 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information This study is prospective, comparative analyses of corneal parameters obtained by various devices having different measuring principles. The Department of Ophthalmology of Kimura eye and internal medicine hospital recruited participants from August 2018. All patients underwent a full ophthalmic examination that included measurement of the spherical equivalent refraction, the corneal curvature, the corneal topography, and the axial length of the eye.

Management information
Registered date
2018 Year 08 Month 07 Day
Last modified on
2018 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038388

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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