UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019008 |
|---|---|
| Receipt number | R000021988 |
| Scientific Title | The research of the functional visual acuity and the prevalence of dry eye among drivers |
| Date of disclosure of the study information | 2015/09/14 |
| Last modified on | 2023/09/27 17:09:50 |
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Basic information
Public title
The research of the functional visual acuity and the prevalence of dry eye among drivers
Acronym
The research of the functional visual acuity and the prevalence of dry eye among drivers
Scientific Title
The research of the functional visual acuity and the prevalence of dry eye among drivers
Scientific Title:Acronym
The research of the functional visual acuity and the prevalence of dry eye among drivers
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the ophthalmic difference between vehicle accident experienced drivers and inexperienced, through questionnaire and ophthalmic examination.
Basic objectives2
Others
Basic objectives -Others
Epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The comparison of the dry eye diagnostic ratio of vehicle accident experienced drivers and inexperienced.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Defined in terms of age limit and gender only.
Key exclusion criteria
Anamnestic history of hypersensitivity to fluorescein.
The investigator/sub investigator has judged that the volunteer is ineligible as study subject.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Kawashima |
Organization
Keio university school of medicine
Division name
Department of ophthalmology
Zip code
160-0016
Address
35 Shinanomachi Shinjuku-ku Tokyo
TEL
03-3353-1211
motoko-k@a3.keio.jp
Public contact
Name of contact person
| 1st name | Motoko |
| Middle name | |
| Last name | Kawashima |
Organization
Keio university school of medicine
Division name
Department of ophthalmology
Zip code
160-0016
Address
35 Shinanomachi Shinjuku-ku Tokyo
TEL
03-3353-1211
Homepage URL
motoko-k@a3.keio.jp
Sponsor or person
Institute
Collaborative joint clinical research organized with Dry Eye Society and Santen Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Santen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Shinanozaka Clinic
Address
Yotsuya Medical Building, 20 Samon-cho, Shinjuku-ku, Tokyo
Tel
03-5366-3006
h-ogura@trcp.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
| 2015 | Year | 09 | Month | 14 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
301
Results
Percentage of dry eye (confirmed + suspected): 219/300 (73.0%)
Proportion of dry eye by accident status: accident-induced (152/198; 76.8%), non-accident-induced (67/102; 65.7%)
Practical visual acuity: visual acuity maintenance (logMAR 0.949), mean visual acuity (logMAR 0.142)
BUT: 5.25 s, Schirmer Test I method: 15.3 mm, keratoconjunctival staining score: 0.5 points
Results date posted
| 2023 | Year | 09 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Persons undergoing driver aptitude tests conducted by NASVA.
Participant flow
Subject background, driving questionnaire,visual questionnaire, subjective symptom identification, Visual Acuity, BUT measurement, keratoconjunctival staining score, Schirmer Test I measurement and adverse events were examined in normal volunteers who had undergone a driver aptitude assessment at NASVA and provided consent.
Adverse events
No adverse event
Outcome measures
Comparison of dry eye prevalence in accident-involved and non-accident-involved groups
Visual Acuity
Tear Film Breakup Time (BUT)
Fluorescein keratoconjunctival staining score
Schirmer test I method
Plan to share IPD
The data presented in this study are not available.
IPD sharing Plan description
The data presented in this study are not available.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study type:Transversal study
Recruiting method:
Drivers who have done the competence test for occupational drivers from Aug. to Sep.2015.
Consenters who meet selection criteria and skirt deselection with written informed consent
Survey item:
Questionnaire
Ophthalmic examination
Management information
Registered date
| 2015 | Year | 09 | Month | 14 | Day |
Last modified on
| 2023 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021988
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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