UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026794 |
|---|---|
| Receipt number | R000029668 |
| Scientific Title | An assessment of driving fitness in patients with visual field defect using driving simulator |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2019/10/07 00:16:14 |
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Basic information
Public title
An assessment of driving fitness in patients with visual field defect using driving simulator
Acronym
An assessment of driving fitness in patients with visual field defect
Scientific Title
An assessment of driving fitness in patients with visual field defect using driving simulator
Scientific Title:Acronym
An assessment of driving fitness in patients with visual field defect
Region
| Japan |
Condition
Condition
glaucoma, retinitis pigmentosa, hemianopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of the loss of specific visual subfields on motor vehicle collisions
Basic objectives2
Others
Basic objectives -Others
To develop a clear warning systems to encourage risky drivers to reconsider driving and avoid potential motor vehicle accidents.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual acuity, visual field, driving simulator, eye tracking
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Active driver with visual field defect
Key exclusion criteria
The patients with cataract or other ocular diseases that could cause visual field defects, the patients with a history of systemic or neurological disease that could reduce the ability to drive. Eyes with unreliable visual field results were also excluded.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeo Fukuchi |
Organization
Graduate School of Medical and Dental Sciences, Niigata University.
Division name
Division of Ophthalmology and Visual Science
Zip code
Address
754, Ichibancho, Asahimachidori, Chuo-ku, Niigata-shi, Niigata, 951-8510
TEL
025-227-2296
tfuku@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shiho Kunimatsu-Sanuki |
Organization
Tohoku University Hospital
Division name
Department of Ophthalmology
Zip code
Address
1-1 Seiryo-cho Aoba-ku Sendai-shi Miyagi-ken 980-8574
TEL
022-717-7294
Homepage URL
shihok-tky@umin.ac.jp
Sponsor or person
Institute
Division of Ophthalmology and Visual Science,Graduate School of Medical and Dental Sciences, Niigata University.
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
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
Secondary IDs
Secondary IDs
YES
Study ID_1
2566
Org. issuing International ID_1
Ethics committee of Niigata University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 03 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2017 | Year | 03 | Month | 31 | Day |
Last modified on
| 2019 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029668
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