UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The influence of multifocal contact lenses on happiness level
Title of the study (Brief title)	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	Kenichi Yoshino
Organization	yoshino eye clinic
Division name	yoshino eye clinic
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	Kenichi Yoshino
Organization	yoshino eye clinic
Division name	yoshino eye clinic
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 03 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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