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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035897
Receipt No. R000040900
Scientific Title visual function and satisfaction with bifocal contact lenses after cataract surgery
Date of disclosure of the study information 2019/02/17
Last modified on 2019/02/17

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Basic information
Public title visual function and satisfaction with bifocal contact lenses after cataract surgery
Acronym bifocal contact lenses after cataract surgery
Scientific Title visual function and satisfaction with bifocal contact lenses after cataract surgery
Scientific Title:Acronym bifocal contact lenses after cataract surgery
Region
Japan

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

Objectives
Narrative objectives1 To investigate visual function and satisfaction with bifocal contact lenses after cataract surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes visual acuity
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria To hope correction of Presbyopia after implanting monofocal IOL
Corneal astigmatism less than 1.5
Best corrected decimal visual acuity more than 0.8
Key exclusion criteria Cases having ophthalmologic diseases except for cataract
Cases judged unsuitable by the research director
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazutaka Kamiya
Organization Kitasato University
Division name Department of Ophthalmology
Zip code
Address 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL 042-778-9920
Email kamiyak-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazutaka Kamiya
Organization Kitasato University
Division name Department of Ophthalmology
Zip code
Address 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL 042-778-9920
Homepage URL
Email kamiyak-tky@umin.ac.jp

Sponsor
Institute Department of Ophthalmology, Kitasato University
Institute
Department

Funding Source
Organization Kitasato University
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

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 17 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
2018 Year 12 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To investigate visual function and satisfaction with bifocal contact lenses after cataract surgery

Management information
Registered date
2019 Year 02 Month 17 Day
Last modified on
2019 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040900

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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