UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the new rebound tonometer;Icare ic100
Title of the study (Brief title)	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	Shunsuke Nakakura
Organization	Saneikai Tsukazaki Hospital
Division name	Ophthalmology
Address	Himeji City Aboshi Waku 68-1
TEL	079-272-8555
Email	shunsukenakakura@yahoo.co.jp

Public contact
Name of contact person	Shunsuke Nakakura
Organization	Saneikai Tsukazaki Hospital
Division name	Ophthalmology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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