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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036335
Receipt No. R000041393
Scientific Title Creating the database of cataract surgery cases
Date of disclosure of the study information 2019/03/29
Last modified on 2019/10/03

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Basic information
Public title Creating the database of cataract surgery cases
Acronym the cataract surgery database
Scientific Title Creating the database of cataract surgery cases
Scientific Title:Acronym the cataract surgery database
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to determine the efficacy and safety of cataract surgery in Keio University Hospital and joint research facilities by collecting the cataract surgery-related data as big data.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy and risk of complications of cataract surgery
Key secondary outcomes past history, preoperative visual acuity, postoperative visual acuity, postoperative complications
term for evaluation: preoperative day, postoperative 1-6 days, postoperative 7-60 days

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients underwent cataract surgery in our hospital and joint research facility who obtained the consent in this study.
Key exclusion criteria Among the patients, those not obtained consent in this study.
Target sample size 20000

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, Japan
TEL 03-3353-1211
Email kazunonegishi@keio.jp

Public contact
Name of contact person
1st name Yasuyo
Middle name
Last name Nishi
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211
Homepage URL
Email yasuyon@a2.keio.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Department of Ophthalmology of 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 Research Ethics Committee of Keio University School of Medicine
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel 03-3353-1211
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
2019 Year 03 Month 29 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
2019 Year 03 Month 28 Day
Date of IRB
2019 Year 03 Month 28 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2029 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Receiving the clinical information (medical record information, image information, questionnaires, etc.) from patients who underwent cataract surgery in our hospital and joint research facilities, we register the data in the entry form on the web and analyze the data using statistical methods.

Management information
Registered date
2019 Year 03 Month 29 Day
Last modified on
2019 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041393

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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