UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008034
Receipt number 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 17:53:08

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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 or person

Institute

Saneikai Tsukazaki Hospital

Institute

Department

Personal name



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

Value
https://center6.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