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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042889
Receipt No. R000048954
Scientific Title Factual survey of motor vehicle driving by patients with visual field defects
Date of disclosure of the study information 2021/01/04
Last modified on 2021/01/03

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Basic information
Public title Factual survey of motor vehicle driving by patients with visual field defects
Acronym Factual survey of motor vehicle driving by patients with visual field defects
Scientific Title Factual survey of motor vehicle driving by patients with visual field defects
Scientific Title:Acronym Factual survey of motor vehicle driving by patients with visual field defects
Region
Japan

Condition
Condition Glaucoma, Retinal disease, Optic nerve disease, Visual pathway disease
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Factual survey of driving performance for patients with visual field defects
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To investigate the relationship between age, disease, severity of visual field defect, questionnaire, and motor vehicle accidents in visual field defects patients
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)Written informed consent: Patients capable of providing written consent by themselves after full explanation of the study details using written information to patients.
2) Patients aged 20 to 80 years old
3) Males and females.
4) Visual field defect by ocular disease
5) Holder of driver's license
Key exclusion criteria 1) History of mental disorder
2) History of strabismus
3) Unable to perform visual field test
4) Patients whom doctor judged to be ineligible for this study.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Kazuhisa
Middle name
Last name Sugiyama
Organization Kanazawa University
Division name Ophthalmology
Zip code 9208641
Address 13-1 Takara-machi, Kanazawa , Ishikawa, Japan
TEL 076-265-2403
Email ksugi@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name Sachiko
Middle name
Last name Udagawa
Organization Kanazawa University Hospital
Division name Ophthalmology
Zip code 9208641
Address 13-1 Takara machi, Kanazawa , Ishikawa, Japan
TEL 0762652000
Homepage URL
Email s-uda@med.kanazawa-u.ac.jp

Sponsor
Institute Japan imaging and perimetry society
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Ophthalmology, Kanazawa University Graduate School of Medical Science
Tajimi Iwase eye clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization Medical ethics committee of Kanazawa university
Address 13-1 Takara machi, Kanazawa , Ishikawa, Japan
Tel 076-265-2103
Email t-isomu@adm.kanazawa-u.ac.jp

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 たじみ岩瀬眼科 (岐阜県)
すずむら眼科 (東京都)
おおくぼ眼科クリニック (石川県)
新潟大学眼科 (新潟県)
三重大学眼科 (三重県)
西葛西・井上病院 (東京都)
東京慈恵会医科大学眼科 (東京都)
慶応義塾大学眼科 (東京都)
北里大学眼科(神奈川県)
埼玉医科大学眼科 (埼玉県)

Other administrative information
Date of disclosure of the study information
2021 Year 01 Month 04 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
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 Enrolling by invitation
Date of protocol fixation
2019 Year 12 Month 31 Day
Date of IRB
2020 Year 01 Month 22 Day
Anticipated trial start date
2020 Year 02 Month 01 Day
Last follow-up date
2021 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2021 Year 01 Month 03 Day
Last modified on
2021 Year 01 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048954

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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