UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021586 |
|---|---|
| Receipt number | R000023833 |
| Scientific Title | The relationship between cataract surgery and subjective happiness in Makati, Philippines |
| Date of disclosure of the study information | 2016/03/23 |
| Last modified on | 2020/02/06 10:02:50 |
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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
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
| 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
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
matsuguma@keio.jp
Sponsor or person
Institute
Keio University School of Medicine, Department of Ophthalmology
Institute
Department
Personal name
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
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023833
