UMIN-CTR Clinical Trial

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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