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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015626
Receipt No. R000018159
Scientific Title Comparison daily activity level between pre- and post-cataract surgery
Date of disclosure of the study information 2014/11/08
Last modified on 2019/05/12

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Basic information
Public title Comparison daily activity level between pre- and post-cataract surgery
Acronym Daily activity level before and after cataract surgery
Scientific Title Comparison daily activity level between pre- and post-cataract surgery
Scientific Title:Acronym Daily activity level before and after cataract surgery
Region
Japan

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

Objectives
Narrative objectives1 To investigate daily activity level before and after cataract surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes METs
Key secondary outcomes

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
40 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients scheduled for bilateral cataract surgery
Key exclusion criteria Patients who have systemic and ocular disease except cataract and history of surgery, which affect visual function.
Patients who use drug which affect visual function.
Patients who have poor motor function.
Patients whose interval of scheduled date of bilateral cataract surgery is over one month.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Kazuno
Middle name
Last name Negishi
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code 160-8582
Address 35, Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3821
Email fwic7788@mb.infoweb.ne.jp

Public contact
Name of contact person
1st name Hidemasa
Middle name
Last name Torii
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code 160-8582
Address 35, Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3821
Homepage URL
Email hidemasatorii@yahoo.co.jp

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

Funding Source
Organization none
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 The institutional review board of Keio University School of Medicine
Address 35, Shinanomachi, Shinjuku-ku, Tokyo
Tel 03-5363-3611
Email med-rinri-jimu@adst.keio.ac.jp

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

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 08 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 Open public recruiting
Date of protocol fixation
2014 Year 11 Month 08 Day
Date of IRB
2014 Year 09 Month 29 Day
Anticipated trial start date
2014 Year 11 Month 08 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To observe daily activity level before and after cataract surgery.

Management information
Registered date
2014 Year 11 Month 07 Day
Last modified on
2019 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018159

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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