UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023037 |
|---|---|
| Receipt number | R000026520 |
| Scientific Title | Changes of Visual function and Subjective symptoms before and after cataract operation |
| Date of disclosure of the study information | 2016/07/06 |
| Last modified on | 2020/07/30 15:49:25 |
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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
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
| 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
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
fwic7788@mb.infoweb.ne.jp
Sponsor or person
Institute
Keio university school of medicine
Institute
Department
Personal name
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
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
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
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 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026520
