UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031926 |
|---|---|
| Receipt number | R000036432 |
| Scientific Title | The influence of multifocal contact lenses on happiness level |
| Date of disclosure of the study information | 2018/03/27 |
| Last modified on | 2018/03/27 20:02:13 |
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Basic information
Public title
The influence of multifocal contact lenses on happiness level
Acronym
Multifocal contact lenses and happiness level
Scientific Title
The influence of multifocal contact lenses on happiness level
Scientific Title:Acronym
Multifocal contact lenses and happiness level
Region
| Japan |
Condition
Condition
presbyopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the influence of multifocal contact lenses on happiness level.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
subjective symptoms of presbyopia
subjective happiness level
quality of sleep
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients come to the research institute and diagnosed to be suitable for multifocal CLs.
Key exclusion criteria
Patients who are judged to be unsuitable as participants because of unability to exact examination or questioner due to decrease in cognitive function or other reason.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Yoshino |
Organization
yoshino eye clinic
Division name
yoshino eye clinic
Zip code
Address
Fugetsudo-honsyabiru 6F, 1-20-10, Ueno, Taito-ku, Tokyo, Japan
TEL
03-3839-5092
yoshino.eye.clinic.kenichi@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Yoshino |
Organization
yoshino eye clinic
Division name
yoshino eye clinic
Zip code
Address
Fugetsudo-honsyabiru 6F, 1-20-10, Ueno, Taito-ku, Tokyo, Japan
TEL
03-3839-5092
Homepage URL
yoshino.eye.clinic.kenichi@nifty.com
Sponsor or person
Institute
yoshino eye clinic
Institute
Department
Personal name
Funding Source
Organization
Bausch&Lomb Japan
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
Address
Tel
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
| 2018 | Year | 03 | Month | 27 | 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
| 2018 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2018 | Year | 03 | Month | 27 | Day |
Last modified on
| 2018 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036432
