UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030537 |
|---|---|
| Receipt number | R000034857 |
| Scientific Title | Evaluation of tonometer in MR-6000 |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2018/06/24 09:35:45 |
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Basic information
Public title
Evaluation of tonometer in MR-6000
Acronym
Evaluation of tonometer in MR-6000
Scientific Title
Evaluation of tonometer in MR-6000
Scientific Title:Acronym
Evaluation of tonometer in MR-6000
Region
| Japan |
Condition
Condition
normal controls and patients with ocular hypertention
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of a new tonometer
Basic objectives2
Others
Basic objectives -Others
Evaluation of accuracy of a new tonometer
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of ocular pressure measured by MR-600 and usual tonometer
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Measuring ocular pressure
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
People who were able to be measured the ocularpressure
Key exclusion criteria
The pregnant
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ueno Shinji |
Organization
Nagoya university hospital
Division name
ophthalmology
Zip code
Address
65 tyusuma-cho Showa-ku Nagoya city
TEL
052-744-2275
ueno@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ueno Shinji |
Organization
Nagoya university hospital
Division name
ophthalmology
Zip code
Address
65 tyusuma-cho Showa-ku Nagoya city
TEL
052-744-2275
Homepage URL
ueno@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
TOMEY corporation
Organization
Division
Category of Funding Organization
Profit organization
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 | 01 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 06 | Month | 20 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 23 | Day |
Last modified on
| 2018 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034857
