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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031926
Receipt No. 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

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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
Email 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
Email yoshino.eye.clinic.kenichi@nifty.com

Sponsor
Institute yoshino eye clinic
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036432

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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