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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004423
Receipt No. R000005283
Scientific Title Cataract surgeries with multifocal intraocular lens
Date of disclosure of the study information 2010/11/01
Last modified on 2010/10/20

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Basic information
Public title Cataract surgeries with multifocal intraocular lens
Acronym A multifocal intraoular lens
Scientific Title Cataract surgeries with multifocal intraocular lens
Scientific Title:Acronym A multifocal intraoular lens
Region
Japan

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

Objectives
Narrative objectives1 Introduction of cataract surgeries with multifocal intraocular lens
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes Naked far and near vision and patient satisfaction
Key secondary outcomes Contrast sensitivity

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The patients who undergo cataract surgeries with multifocal intraocular lens
Interventions/Control_2 The patients who undergo cataract surgeries with monofocal intraocular lens
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
50 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria The patients who hope to undergo the cataract surgery with multi-focal intraocular lens
1 The patients who are scheduled for both eyes cataract surgery
2 The patients who was judged only cataract as the factor of visual disturbance
3 The patients who have no severe systemic illnesses and functional disturbance
Key exclusion criteria 1 The patients who cannot understand the feature of multi-focal intraocular lens
2 The patients who have other eye diseases that obstruct the funtion of multi-focal intraocular lens
Target sample size 50

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hiroshi Eguchi
Organization Tokushima University Hospital
Division name D
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima-city
TEL 088-633-7163
Email

Public contact
1st name of contact person
1st name
Middle name
Last name
Organization Tokushima University Hospital
Division name The Department of Ophthalmology
Zip code
Address 3-18-15 Kuramoto-cho, Tokushima-city
TEL
Homepage URL
Email

Sponsor
Institute Department of Ophthalmology,Tokushima University Hospital
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
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

Other administrative information
Date of disclosure of the study information
2010 Year 11 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 Preinitiation
Date of protocol fixation
2010 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2011 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 10 Month 20 Day
Last modified on
2010 Year 10 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005283

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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