UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042889 |
|---|---|
| Receipt number | 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 15:05:00 |
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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
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
s-uda@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Japan imaging and perimetry society
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048954
