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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030537
Receipt No. 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

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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
Email 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
Email ueno@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034857

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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