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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002057
Receipt No. R000002509
Scientific Title The risk of motor vehicle collision in patients with glaucoma
Date of disclosure of the study information 2009/06/15
Last modified on 2009/12/09

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Basic information
Public title The risk of motor vehicle collision in patients with glaucoma
Acronym The risk of motor vehicle collision in patients with glaucoma
Scientific Title The risk of motor vehicle collision in patients with glaucoma
Scientific Title:Acronym The risk of motor vehicle collision in patients with glaucoma
Region
Japan

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

Objectives
Narrative objectives1 To investigate the risk of motor vehicle collision in glaucoma
Basic objectives2 Others
Basic objectives -Others none
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes previous self-reported motor vehicle collision
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria consecutive glaucoma patients who come to the outpatients clinic and patients who come to the clinic for annual check.
Key exclusion criteria Those who cannot wright the question sheet
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenya Yuki
Organization Keio University School of Medicine
Division name Department of ophthalmology
Zip code
Address shinjyuku-ku shinanomachi 35
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Keio University School of Medicine
Division name Department of ophthalmology
Zip code
Address
TEL
Homepage URL
Email glaucoma.keio@gmail.com

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Tanabe eye clinic
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
2009 Year 06 Month 15 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The number of subjects with MVC experience were higher in POAG patients compared to the control [POAG; 7(7/121=5.7%) control;5 (5/144=3.4%)],relatively. No other significant difference was observed. In subgroup analysis, we compared the number of subjects with MVC experience between POAG patients with the mean deviation in hemi-visual field over -10 dB and controls. The number of MVC in sever POAG patients was significantly higher than controls [severe POAG; 5 (5/20=25.0%) control 5 (5/144=3.4%) P=0.002; fisher`s exact test)]. Corrected visual acuity was significantly worse in severe POAG group than controls. No other significant difference was observed. After the logistic regression analysis, the odds ratio for MVC in severe POAG was 16.0 (P=0.001;95%CI: 2.9-88.0) . 
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 10 Month 12 Day
Date of IRB
Anticipated trial start date
2008 Year 11 Month 01 Day
Last follow-up date
2009 Year 11 Month 01 Day
Date of closure to data entry
2009 Year 12 Month 01 Day
Date trial data considered complete
2009 Year 12 Month 01 Day
Date analysis concluded
2009 Year 12 Month 01 Day

Other
Other related information none

Management information
Registered date
2009 Year 06 Month 09 Day
Last modified on
2009 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002509

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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