UMIN-CTR Clinical Trial

Basic information
Public title	The relationship between cataract surgery and subjective happiness in Makati, Philippines
Acronym	The relationship between cataract surgery and subjective happiness in Makati
Scientific Title	The relationship between cataract surgery and subjective happiness in Makati, Philippines
Scientific Title:Acronym	The relationship between cataract surgery and subjective happiness in Makati
Region	Japan Asia(except Japan)

Condition
Condition	Cataract
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	As positive psychology has revealed that happiness is the ultimate goal for many people, World Health Organization (WHO) also put an emphasis on the importance of happiness as a critical component of health. As this trend, new studies relating to happiness has started to be conducted in the field of ophthalmology, too such as the study of the relationship between subjective happiness with dry eye syndrome and happiness with cataract surgery in Japan. In the study of happiness with cataract surgery conducted in Japan, it was observed that subjective happiness was increased at one point after cataract surgery, but it went back to the set point in a year. Here in the Philippines, we are going to conduct a survey of patients' subjective happiness before and after cataract surgery. This survey will serve as the future's indication of the relationship between ophthalmologic medication and people's happiness and quality of life.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Subjective Happiness Scale before and 1, 3, 6, and 12 months after the cataract surgery
Key secondary outcomes	Eye sight

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
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	1) Persons who have cataract surgery at Pacific Eye and Laser Institute, Makati, Philippines since November 1, 2015. 2) Persons who can make agreement 3) Persons who can understand and answer the questionnaires in English 4) Persons who cannot be in the healthy condition according to their doctors
Key exclusion criteria	1) Persons who cannot communicate in English 2) Persons under 18 years old
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuo Tsubota
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Zip code
Address	35, Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-5363-3821
Email	tsubota@z3.keio.jp

Public contact
Name of contact person	1st name Middle name Last name Shinichiro Matsuguma
Organization	Keio University Graduate School of Medicine
Division name	Department of Ophthalmology
Zip code
Address	35, Shinanomachi, Shinjuku-ku, Tokyo
TEL	080-1530-9781
Homepage URL
Email	matsuguma@keio.jp

Sponsor
Institute	Keio University School of Medicine, Department of Ophthalmology
Institute
Department

Funding Source
Organization	Keio University School of Medicine, Department of Ophthalmology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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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	Peregrine Eye and Laser Institute(フィリピン共和国マカティ市）

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 23 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
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Results Delayed
Results Delay Reason
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Baseline Characteristics
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Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 19 Day
Date of IRB	2015 Year 07 Month 31 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The study design is prospective longitudinal observational study. Those who will have cataract surgery at Peregrine Eye Laser Institute since March 2016 and meet the study criteria, will be recruited as participants.The outcome measures are Subjective Happiness Scale, the National Eye Institute 25-Item Visual Function Questionnaire(VFQ-25), medical record (Date, Sex, Age, Naked eye, Subjective refraction, Corrected visual acuity, Type of lens), and satisfaction with the cataract surgery.

Management information
Registered date	2016 Year 03 Month 23 Day
Last modified on	2020 Year 02 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023833