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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026217
Receipt No. R000030013
Scientific Title Prospective observational study on cataract surgery with multifocal intraocular lens implantation
Date of disclosure of the study information 2017/03/01
Last modified on 2019/01/16

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Basic information
Public title Prospective observational study on cataract surgery with multifocal intraocular lens implantation
Acronym Prospective observational study on cataract surgery with multifocal intraocular lens implantation
Scientific Title Prospective observational study on cataract surgery with multifocal intraocular lens implantation
Scientific Title:Acronym Prospective observational study on cataract surgery with multifocal intraocular lens implantation
Region
Japan

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

Objectives
Narrative objectives1 To investigate surgical results of multifocal intraocular lens implantation and patient's satisfaction in Japan
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Corrected Visual acuity (Distance,near)
Uncorrected Visual acuity (Distance,near)
Key secondary outcomes usage of spectacles,questionnaire,refraction,contrast sensitivity

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 undergo cataract surgery with multifocal intraocular lens implantation at the institute registered to the registry system of advanced medical treatment( cataract surgery with multifocal intraocular lens implantation) that is administrated by the Japanese society of cataract and refractive surgery.
Key exclusion criteria Patients who don't give their consent to this study
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroko Bissen-Miyajima
Organization Tokyo Dental College Suidobashi Hospital
Division name Department of ophthalmology
Zip code
Address 2-9-18, Misakicho, Chiyoda-ku, Tokyo, Japan
TEL 03-5275-1856
Email bissen@tdc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Yamanishi
Organization Japanese Society of Cataract and Refractive Surgery(JSCRS) questionnaire survey working group
Division name Secretariat, Japanese Society of Cataract and Refractive Surgery(JSCRS)
Zip code
Address 3-2-16, Misakicho, Chiyoda-ku, Tokyo Japan
TEL 03-5226-7750
Homepage URL
Email jscrs@jscrs.jp

Sponsor
Institute Keio university school of medicine
Institute
Department

Funding Source
Organization Keio university school of medicine
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 慶應委義塾大学病院ほか、日本屈折矯正手術学会より日本白内障屈折矯正手術学会の先進医療(多焦点眼内レンズを用いた水晶体再建術)登録システムに登録された施設

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 01 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
2017 Year 02 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2017 Year 02 Month 20 Day
Last modified on
2019 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030013

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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