UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033672 |
|---|---|
| Receipt number | R000038388 |
| Scientific Title | 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 | 2023/01/23 18:00:52 |
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Basic information
Public title
Intercomparison analysis of corneal parameters obtained by various devices having different measuring principles.
Acronym
Comparison of corneal parameters.
Scientific Title
Intercomparison analysis of corneal parameters obtained by various devices having different measuring principles.
Scientific Title:Acronym
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
247
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yugo Kimura |
Organization
Kimura eye and internal medicine hospital
Division name
Department of ophthalmology
Zip code
Address
3-15 Takaramachi, Kure, Hiroshima
TEL
0823225544
ky.kimuraeye@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Nakao |
Organization
Kimura eye and internal medicine hospital
Division name
Department of ophthalmology
Zip code
Address
3-15 Takaramachi, Kure, Hiroshima
TEL
0823225544
Homepage URL
Yoshitaka.nakao@kimura-eye.or.jp
Sponsor or person
Institute
Kimura eye and internal medicine hospital
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 06 | Month | 23 | Day |
Date of IRB
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
Other
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
| 2023 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038388
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
