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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007226
Receipt No. R000008511
Scientific Title Department of Ophthalmology, Gifu University Graduate School of Medicine, Gifu, Japan
Date of disclosure of the study information 2012/02/10
Last modified on 2015/02/05

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Basic information
Public title Department of Ophthalmology, Gifu University Graduate School of Medicine, Gifu, Japan
Acronym Intraocular pressure alterations after visual field testing
Scientific Title Department of Ophthalmology, Gifu University Graduate School of Medicine, Gifu, Japan
Scientific Title:Acronym Intraocular pressure alterations after visual field testing
Region
Japan

Condition
Condition Glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine whether the intraocular pressure is significantly altered after visual field testing in eyes with open-angle glaucoma
Basic objectives2 Others
Basic objectives -Others none
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

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

Not applicable
Gender Male and Female
Key inclusion criteria Glaucoma
Key exclusion criteria none
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Sawada
Organization Gifu University Graduate School of Medicine
Division name Ophthalmology
Zip code
Address 1-1 Yanagido, Gifu-shi , Japan.
TEL 058-230-5287
Email sawadaa-gif@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Sawada
Organization Gifu University Graduate School of Medicine
Division name Ophthalmology
Zip code
Address 1-1 Yanagido, Gifu-shi , Japan.
TEL 058-230-5287
Homepage URL
Email sawadaa-gif@umin.ac.jp

Sponsor
Institute Gifu University Graduate School of Medicine
Institute
Department

Funding Source
Organization Gifu University Graduate School of Medicine
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 02 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The baseline refractive error (spherical equivalent) was 4.13 +/- 3.61 diopters (D) in the right eye (OD) and 4.05 +/- 3.63 D in the left eye (OS).  The average VF testing time was 7.5 +/- 1.4 minutes for both eyes.  The average baseline IOP was 12.8 +/- 2.9 mmHg OD and 12.6 +/- 2.8 mmHg OS.  After the VF testing of the right eye, the average IOP of the right eye decreased significantly to 12.3 +/- 2.6 mmHg (p = 0.001), but the IOP (12.5 +/- 2.6 mmHg) of the left eye was not significantly unchanged (p = 0.190).  Following the VF testing of the left eye, the IOP in the right was 12.2 +/- 2.6 mmHg (p = 0.252) and that in the left eye was 12.4 +/- 2.7 mmHg (p = 0.487).  An elevation of more than 2 mmHg in the IOP after the VF testing was found in 2.8% of the right eyes and 0.9% of the left eyes.  The refractive error was not significantly changed after the VF testing.  Multivariate analysis showed statistically significant correlations between the IOP decrease after the VF testing and the baseline IOP (p = 0.000) and the central corneal thickness (p = 0.034). 
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
2008 Year 02 Month 10 Day
Date of IRB
Anticipated trial start date
2008 Year 02 Month 01 Day
Last follow-up date
2013 Year 03 Month 03 Day
Date of closure to data entry
2013 Year 03 Month 03 Day
Date trial data considered complete
2013 Year 03 Month 03 Day
Date analysis concluded
2013 Year 03 Month 03 Day

Other
Other related information prospective study

Management information
Registered date
2012 Year 02 Month 04 Day
Last modified on
2015 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008511

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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