UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008034
Receipt No. R000009456
Scientific Title Comparison of intraocular pressure measurements on the bed by four portable tonometers.
Date of disclosure of the study information 2012/05/28
Last modified on 2017/01/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Comparison of intraocular pressure measurements on the bed by four portable tonometers.
Acronym Comparison of intraocular pressure on the bed.
Scientific Title Comparison of intraocular pressure measurements on the bed by four portable tonometers.
Scientific Title:Acronym 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
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 +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)

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
2012 Year 05 Month 28 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
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.
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
2012 Year 05 Month 26 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.