UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008320
Receipt number R000009796
Scientific Title Comparison of intraocular pressure measurements on the bed by four portable tonometer including icare pro.
Date of disclosure of the study information 2012/07/15
Last modified on 2013/02/25 11:05:56

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Basic information

Public title

Comparison of intraocular pressure measurements on the bed by four portable tonometer including icare pro.

Acronym

Comparison of intraocular pressure on the supine position.

Scientific Title

Comparison of intraocular pressure measurements on the bed by four portable tonometer including icare pro.

Scientific Title:Acronym

Comparison of intraocular pressure on the supine position.

Region

Japan


Condition

Condition

Healthy volunteers

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate intraocular pressure on the bed among four portable tonometers and thier 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

1 Subjects with any ocular diseases.
2 Subjects with previous any ocular surgery.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shunsuke Nakakura

Organization

Saneikai Tsukazaki Hospital

Division name

Ophthalmolgy

Zip code


Address

Himeji City Aboshi Waku 68-1

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Shunsuke Nakakura

Organization

Saneikai Tsukazaki Hospital

Division name

Ophthalmolgy

Zip code


Address

Himeji City Aboshi Waku 68-1

TEL

+81-79-272-8555

Homepage URL


Email

shunsukenakakura@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 07 Month 15 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

The repeatability of Icare PRO was slightly lower in the supine position than in the sitting position. Although Icare PRO underestimated IOP values in eyes with higher IOP when compared with Tonopen XL and Kowa HAT in both positions, we observed good inter-device agreement between Icare PRO and both Tonopen XL and Kowa HAT.

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 07 Month 03 Day

Date of IRB


Anticipated trial start date

2012 Year 07 Month 01 Day

Last follow-up date

2012 Year 10 Month 01 Day

Date of closure to data entry

2012 Year 12 Month 01 Day

Date trial data considered complete

2012 Year 12 Month 01 Day

Date analysis concluded

2013 Year 01 Month 31 Day


Other

Other related information

To evaluate intraocular pressure by icare pro, TonopenXL, Diaton tonometer and handled applanation tonometer


Management information

Registered date

2012 Year 07 Month 02 Day

Last modified on

2013 Year 02 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009796


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name