UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051319 |
|---|---|
| Receipt number | R000058536 |
| Scientific Title | A Study Focusing on the Relationship between Objective Assessment of Ocular Function and Subjective Vision and Health Status of professional drivers |
| Date of disclosure of the study information | 2023/06/12 |
| Last modified on | 2023/06/11 17:51:40 |
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Basic information
Public title
A Study Focusing on the Relationship between Objective Assessment of Ocular Function and Subjective Vision and Health Status of professional drivers
Acronym
A Study Focusing on the Relationship between Objective Assessment of Ocular Function and Subjective Vision and Health Status of professional drivers
Scientific Title
A Study Focusing on the Relationship between Objective Assessment of Ocular Function and Subjective Vision and Health Status of professional drivers
Scientific Title:Acronym
A Study Focusing on the Relationship between Objective Assessment of Ocular Function and Subjective Vision and Health Status of professional drivers
Region
| Japan |
Condition
Condition
Healthy Adults
Older Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to find parameters that correlate various visual function measures with driver near-miss accidents in order to quickly identify situations that require attention while driving for professional drivers. A secondary objective is to determine the driver's current visual function.
Basic objectives2
Others
Basic objectives -Others
Correlate the parameters obtained from the visual function measurement with the parameters of near miss accidents.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlate the parameters obtained from the visual function measurement with the parameters of near miss accidents.
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Professional drivers who are between 20 and 69 years of age at the time of consent.
(ii) Persons who have been fully informed of the purpose and content of this study, have the capacity to consent, understand the contents well, and are able to consent to participation in this study in writing or by electromagnetic means.
Key exclusion criteria
(i) Persons who have difficulty in undergoing testing at the specified measurement time
(ii) Other subjects deemed inappropriate as research subjects by the principal investigator or subinvestigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hisae |
| Middle name | |
| Last name | Aoyagi |
Organization
ROHTO PHARMACEUTICAL CO., LTD.
Division name
Health Science Research Planning Division
Zip code
105-0022
Address
Shiodome Building 20th floor, 1-2-20 Kaigan, Minato-ku, Tokyo 105-0022, Japan
TEL
03-6832-6010
aoyagi@rohto.co.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Takagi |
Organization
ROHTO PHARMACEUTICAL CO., LTD
Division name
TOHOKU-COI Promotion Office, Sendai Sales Office HB East Japan Division
Zip code
544-8666
Address
1-8-1, Tatsumi-nishi, Ikuno-ku, Osaka 544-8666, Japan
TEL
06-6758-1231
Homepage URL
eyecare-support@rohto.co.jp
Sponsor or person
Institute
ROHTO PHARMACEUTICAL CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
ROHTO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee for Clinical Research, etc., Rohto Pharmaceutical Co.
Address
1-8-1, Tatsumi-nishi, Ikuno-ku, Osaka 544-8666, Japan
Tel
06-6758-1231
rohtoirb@rohto.co.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 12 | 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
| 2023 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2023 | Year | 06 | Month | 11 | Day |
Last modified on
| 2023 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058536
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
