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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008497
Receipt No. R000009988
Scientific Title Intraocular pressure comparisons between supine and sitting position by portable tonometers, and the evaluation the effect of ocular biometry.
Date of disclosure of the study information 2012/07/23
Last modified on 2013/02/25

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Basic information
Public title Intraocular pressure comparisons between supine and sitting position by portable tonometers, and the evaluation the effect of ocular biometry.
Acronym Supine and sitting IOP measurements with ocualr biometry
Scientific Title Intraocular pressure comparisons between supine and sitting position by portable tonometers, and the evaluation the effect of ocular biometry.
Scientific Title:Acronym Supine and sitting IOP measurements with ocualr biometry
Region
Japan

Condition
Condition Healty volunteers
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the IOP by postural change and the effect of ocular biometry
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 with sigh an informed consent form
Key exclusion criteria Subjects with any ocular diseases and surgeries
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 Department of Ophthalmology
Zip code
Address Himeji City aboshi waku 68-1
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Saneikai Tsukazaki Hospital
Division name Department of Ophthalmology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Saneikai Tsukazaki Hospital
Institute
Department

Funding Source
Organization saneikai tsukazaki hospital
Organization
Division
Category of Funding Organization Other
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 23 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 22 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2013 Year 01 Month 31 Day

Other
Other related information IOP were measured by iCare pro, TonopenXL and Handheld applanation tonometer and the average of the three sets of the readings were used for subsequent analysis

Management information
Registered date
2012 Year 07 Month 23 Day
Last modified on
2013 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009988

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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