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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031928
Receipt No. R000036464
Scientific Title Evaluation of the new rebound tonometer;Icare ic100
Date of disclosure of the study information 2018/03/27
Last modified on 2018/11/22

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Basic information
Public title Evaluation of the new rebound tonometer;Icare ic100
Acronym Evaluation of the new rebound tonometer;Icare ic100
Scientific Title Evaluation of the new rebound tonometer;Icare ic100
Scientific Title:Acronym Evaluation of the new rebound tonometer;Icare ic100
Region
Japan

Condition
Condition Healthy subjects and glaucoma patients.
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the IOP tendency of new Icare ic100 compared to the previous tonometers. Additionally, the effect of upper eyelid clutching for IOP values.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes IOP
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
18 years-old <
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Healthy subjects
Without ocular diseases
Acceptable Goldmann applanation tonometer

Glaucoma patients
Acceptable Goldmann applanation tonometer
Key exclusion criteria Subjects or patients do not fit the above inclusion data.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsuke Nakakura
Organization Saneikai Tsukazaki Hospital
Division name Ophthalmology
Zip code
Address Himeji City Aboshi Waku 68-1
TEL 079-272-8555
Email shunsukenakakura@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunsuke Nakakura
Organization Saneikai Tsukazaki Hospital
Division name Ophthalmology
Zip code
Address Himeji City Aboshi Waku 68-1
TEL 079-272-8555
Homepage URL
Email shunsukenakakura@yahoo.co.jp

Sponsor
Institute Saneikai Tsukazaki Hospital
Institute
Department

Funding Source
Organization Self funding
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
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 03 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

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
2018 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Now on going

Management information
Registered date
2018 Year 03 Month 27 Day
Last modified on
2018 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036464

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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