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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035400
Receipt No. R000040336
Scientific Title Comparison between blue-blocking and violet-blocking intraocular lenses.
Date of disclosure of the study information 2018/12/29
Last modified on 2019/06/30

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Basic information
Public title Comparison between blue-blocking and violet-blocking intraocular lenses.
Acronym Comparison of blue-blocking and violet-blocking IOLs
Scientific Title Comparison between blue-blocking and violet-blocking intraocular lenses.
Scientific Title:Acronym Comparison of blue-blocking and violet-blocking IOLs
Region
Japan

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

Objectives
Narrative objectives1 Prospective comparison of surgical outcomes between blue-blocking and violet-blocking intraocular lenses
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual functions at 1 year postoperatively
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are 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 Cataract surgery using blue-blocking intraocular lenses
Interventions/Control_2 Cataract surgery using violet-blocking intraocular lenses
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 Eligible for standard cataract surgery
Key exclusion criteria Those having diseases which affect visual functions
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Tetsuro
Middle name
Last name Oshika
Organization University of Tsukuba
Division name Department of Opohthalmology
Zip code 305-8575
Address 1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL 029-853-3148
Email oshika@eye.ac

Public contact
Name of contact person
1st name Tetsuro
Middle name
Last name Oshika
Organization University of Tsukuba
Division name Department of Ophthalmology
Zip code 305-8575
Address 1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL 029-853-3148
Homepage URL
Email oshika@eye.ac

Sponsor
Institute Division of Ophthalmology, Ryugasaki Saiseikai Hospital
Institute
Department

Funding Source
Organization Division of Ophthalmology, Ryugasaki Saiseikai Hospital
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 University of Tsukuba
Address 1-1-1 Tennoudai, Tsukuba
Tel 029-853-3
Email oshika@eye.ac

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
2018 Year 12 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 Completed
Date of protocol fixation
2018 Year 12 Month 29 Day
Date of IRB
2018 Year 01 Month 10 Day
Anticipated trial start date
2019 Year 01 Month 10 Day
Last follow-up date
2019 Year 06 Month 30 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 12 Month 29 Day
Last modified on
2019 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040336

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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