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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016749
Receipt No. R000019438
Scientific Title Perfluorocarbon-Assisted vitrectomy for the management of lens luxation
Date of disclosure of the study information 2015/03/16
Last modified on 2019/03/12

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Basic information
Public title Perfluorocarbon-Assisted vitrectomy for the management of lens luxation
Acronym Perfluorocarbon-Assisted vitrectomy for the management of lens luxation
Scientific Title Perfluorocarbon-Assisted vitrectomy for the management of lens luxation
Scientific Title:Acronym Perfluorocarbon-Assisted vitrectomy for the management of lens luxation
Region
Japan

Condition
Condition lens luxation
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and safety about perfluorocarbon-Assisted vitrectomy for the management of lens luxation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes complication, visual acuity
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 From February 20 in 2015 to December 31, 2017. Vitrectomy and lensectomy using perfluorocarbon liquid, 1vial(5ml), for lens luxation. The times and the frequency are once.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Primary lens luxation
Key exclusion criteria including retinal disorders
Target sample size 15

Research contact person
Name of lead principal investigator
1st name TAIJI
Middle name
Last name SAKAMITO
Organization Kagoshima University
Division name Ophthalmology
Zip code 8908520
Address 8-35-1 Sakruagaoka, Kagoshima 890-8520
TEL +81-99-275-5402
Email tsakamot@m3.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name Toshifumi
Middle name
Last name Yamashita
Organization Kagoshima University
Division name Ophthalmology
Zip code 8908520
Address 8-35-1 Sakruagaoka, Kagoshima 890-8520
TEL +81-99-275-5402
Homepage URL
Email yyamatos@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute Ophthalmology, Kagoshima University
Institute
Department

Funding Source
Organization Ophthalmology, Kagoshima University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kagoshima University Hospital
Address 8-35-1 Sakruagaoka, Kagoshima
Tel 099-275-5402
Email yyamatos@m.kufm.kagoshima-u.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 鹿児島大学病院(鹿児島県)

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 16 Day

Related information
URL releasing protocol No data
Publication of results Unpublished

Result
URL related to results and publications No data
Number of participants that the trial has enrolled 12
Results
No data
Results date posted
2019 Year 03 Month 12 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No data
Participant flow
No data
Adverse events
No data
Outcome measures
No data
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 02 Month 20 Day
Date of IRB
2015 Year 01 Month 06 Day
Anticipated trial start date
2015 Year 03 Month 16 Day
Last follow-up date
2017 Year 12 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
2015 Year 03 Month 09 Day
Last modified on
2019 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019438

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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