UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of intraocular pressure measurements on the bed by four portable tonometers.
Title of the study (Brief title)	Comparison of intraocular pressure on the bed.
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Ophthalmology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate intraocular perssure among four portable tonometers and their agreements.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intraocular pressure
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1 Healty volunteers 2 Subjects who sign an informed consent form.
Key exclusion criteria	Subjects with any ocular diseases.
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	+81-79-272-8555
Homepage URL
Email	shunsuekenakakura@yahoo.co.jp

Sponsor
Institute	Saneikai Tsukazaki Hospital
Institute
Department

Funding Source
Organization	None
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	2012 Year 05 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 05 Month 26 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date	2012 Year 07 Month 21 Day
Date of closure to data entry	2012 Year 07 Month 23 Day
Date trial data considered complete	2012 Year 07 Month 23 Day
Date analysis concluded	2012 Year 07 Month 23 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	On the bed intraocular pressure measurements using four portable tonometers, the agreement between iCare - TonopenXL, iCare - Perkins and TonopenXL - Perkins appeared clinical acceptable level. IOP on the bed were almost independent of central corneal thickness, axial length.
Other related information	Intraocular pressure is measuerd on the bed by Diaton tonometer, Perkins tonometer, iCare and Tonopen XL.

Management information
Registered date	2012 Year 05 Month 26 Day
Last modified on	2017 Year 01 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009456