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

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 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


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


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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name