UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053889 |
|---|---|
| Receipt number | R000061515 |
| Scientific Title | Research regarding employment and other information gathering for the visually impaired |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/11/12 11:54:06 |
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Basic information
Public title
Research regarding employment and other information gathering for the visually impaired
Acronym
Research on employment and other information gathering for the visually impaired
Scientific Title
Research regarding employment and other information gathering for the visually impaired
Scientific Title:Acronym
Research on employment and other information gathering for the visually impaired
Region
| Japan |
Condition
Condition
Visual impairment equivalent to the Visual Impairment Certificate
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To collect data on employment, as well as other information on the visually impaired.
Basic objectives2
Others
Basic objectives -Others
Assess the patient's willingness to work at the initial visit and at a visit approximately 9 months after the initial visit.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Employment Willingness of the Visually Impaired as Assessed by the Wong-Baker FACES Foundation Scale
Key secondary outcomes
Percentage working in Visit2
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons who have been diagnosed with some eye diseases, have visual impairment equivalent to the visually impaired person's certificate, can visit the Department of Ophthalmology at Keio University Hospital during the study period, and are eligible for employment (18-60 years old ).
Key exclusion criteria
Persons who have been diagnosed with or are undergoing treatment for dementia or psychiatric disorders, persons who are unable to work due to reasons other than ocular disease, persons with a history or suspected or confirmed diagnosis of alcohol or other drug addiction, persons who are unable to understand the evaluations, tests and procedures, persons who, in the judgment of the principal investigator, are considered at risk of being unable to perform the study, and other persons who are considered by the principal investigator, principal investigator or physician in charge to be unsuitable for the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toshihide |
| Middle name | |
| Last name | Kurihara |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0353134132
kurihara@z8.keio.jp
Public contact
Name of contact person
| 1st name | Toshiihide |
| Middle name | |
| Last name | Kurihara |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0353134132
Homepage URL
kurihara@z8.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
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
Keio University School of Medicine, Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
Other administrative information
Date of disclosure of the study information
| 2024 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2024 | Year | 03 | Month | 18 | Day |
Last modified on
| 2024 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061515
