UMIN-CTR Clinical Trial

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