UMIN-CTR Clinical Trial

Basic information
Public title	Changes of Visual function and Subjective symptoms before and after cataract operation
Acronym	Changes of Visual function and Subjective symptoms before and after cataract operation
Scientific Title	Changes of Visual function and Subjective symptoms before and after cataract operation
Scientific Title:Acronym	Changes of Visual function and Subjective symptoms before and after cataract operation
Region	Japan

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

Objectives
Narrative objectives1	To investigate changes of subjective happiness and visual function before and after cataract operation.
Basic objectives2	Others
Basic objectives -Others	To compare subjective happeniss scale before and after cataract operation.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Subjective Happiness Scale
Key secondary outcomes	quality of sleep, visual function

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
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Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who had cataract operation and are 20 years old or more.
Key exclusion criteria	Patients who are judged to be inappropriate as a subject due to various reasons, such as the patients can't undergo ocular examinations or reply the questionnaires because of decreased cognitive function.
Target sample size	750

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuno Negishi
Organization	Keio university school of medicine
Division name	Department of ophthalmology
Zip code
Address	Shinanomachi 35, Shinjuku-ku, Tokyo Japan
TEL	81333598302
Email	fwic7788@mb.infoweb.ne.jp

Public contact
Name of contact person	1st name Middle name Last name Kazuno Negishi
Organization	Keio university school of medicine
Division name	Department of ophthalmology
Zip code
Address	Shinanomachi 35, Shinjuku-ku, Tokyo Japan
TEL	81333598302
Homepage URL
Email	fwic7788@mb.infoweb.ne.jp

Sponsor
Institute	Keio university school of medicine
Institute
Department

Funding Source
Organization	Keio university school of medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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IRB Contact (For public release)
Organization
Address
Tel
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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	慶應義塾大学病院（東京都） 等々力眼科（東京都） みなとみらいアイクリニック（神奈川県）

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 06 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
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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 03 Month 01 Day
Date of IRB	2015 Year 12 Month 04 Day
Anticipated trial start date	2016 Year 03 Month 23 Day
Last follow-up date	2020 Year 07 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Patients who had cataract operation answer the questionnaire about subjective happiness and Pittsburgh Sleep Quality Index. We gather information about the patient(for example,age,sex,past medical history) from medical record. Then we investigate changes of subjective happiness and visual function before and after cataract operation.

Management information
Registered date	2016 Year 07 Month 06 Day
Last modified on	2020 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026520