UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	prospective study of vitrectomy with heavy silicone oil for Japanese patients
Title of the study (Brief title)	prospective study of vitrectomy with heavy silicone oil for Japanese patients
Region	Japan

Condition
Condition	proliferative vitreoretinopathy
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of treatment for proliferative vitreoretinopathy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	visual acuity
Key secondary outcomes	postoperative complications

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	October 2011~December 2020 tamponade agent of vitrectomy for proliferative vitreoretinopathy
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	proliferative vitreoretinopathy
Key exclusion criteria	proliferative vitreoretinopathy
Target sample size	15

Research contact person
Name of lead principal investigator	Taiji Sakamoto
Organization	Graduate School of Medical and Dental Science, Kagoshima University
Division name	Department of Ophthalmology
Address	Sakuragaoka 8-35-1,Kagoshima
TEL	099-275-5111
Email	tsakamot@m3.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	Toshifumi Yamashita
Organization	Graduate School of Medical and Dental Science, Kagoshima University
Division name	Department of Ophthalmology
Address	Sakuragaoka 8-35-1,Kagoshima
TEL	099-275-5111
Homepage URL
Email	yyamatos@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Department of Ophthalmology, Graduate School of Medical and Dental Science, Kagoshima University
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)

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	2012 Year 01 Month 22 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 10 Month 31 Day
Anticipated trial start date	2011 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 01 Month 19 Day
Last modified on	2017 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008362