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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032532
Receipt No. R000030889
Scientific Title Cataract surgery using multifocal intraocular lens
Date of disclosure of the study information 2018/05/09
Last modified on 2019/05/24

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Basic information
Public title Cataract surgery using multifocal intraocular lens
Acronym Cataract surgery using multifocal intraocular lens
Scientific Title Cataract surgery using multifocal intraocular lens
Scientific Title:Acronym Cataract surgery using multifocal intraocular lens
Region
Japan

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

Objectives
Narrative objectives1 To study the contribution for improving
quality of vision and life by cataract
surgery using multifocal intraocular lens
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of postoperative vision
Key secondary outcomes Patinet's satisfaction, Percentage of wearing glasses.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 cataract surgery using multifocal intraocular lens
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
85 years-old >=
Gender Male and Female
Key inclusion criteria The patients having cataract and understandable at the future of multifocal intraocular lems
Key exclusion criteria The patients expecting postoperatice poor visual acuity
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Chikako
Middle name
Last name Suto
Organization Tokyo Women's Medical University Medical Center East
Division name Department of Ophthalmology
Zip code 116-8567
Address 2-1-10 Nishiogu, Arakawa-ku, Tokyo 116-8567,Japan
TEL 03-3810-1111
Email suto.chikako@twmu.ac.jp

Public contact
Name of contact person
1st name Chikako
Middle name
Last name Suto
Organization Tokyo Women's Medical University Medical Center East
Division name Department of Ophthalmology
Zip code 116-8567
Address 2-1-10 Nishiogu, Arakawa-ku, Tokyo 116-8567,Japan
TEL 03-3810-1111
Homepage URL
Email suto.chikako@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University Medical Center East
Institute
Department

Funding Source
Organization Tokyo Women's Medical University Medical Center East
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 Tokyo Women's Medical University
Address 8-1Kawada-cho, Shinjuku-Ku, Tokyo
Tel 03-3353-8111
Email kobayakawa.naomi@twmu.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 東京女子医科大学東医療センター眼科

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 09 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 5
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 04 Month 11 Day
Date of IRB
2017 Year 04 Month 11 Day
Anticipated trial start date
2017 Year 04 Month 11 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 09 Day
Last modified on
2019 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030889

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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