UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical evaluation of new vitrectomy system:EVA
Title of the study (Brief title)	Clinical evaluation of EVA
Region	Japan

Condition
Condition	Retinal detachment, Epimacular proliferation, macular hole, Diabetic retinopathy, Retinal vein occlusion, Vitreous hemorrhage
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Vitrectomy is indicated for various vitreoretial disorders, including retinal dtachment, epimacular proliferation, diabetic retinopathy, retinal vein occlusion, and vitreous hemorrhage. In order to perform vitrectomy, vitrectomy surgery system is necessary. Dutch Ophthalmic Research Center (DORC) has introduced a new vitrectomy system, EVA, which has already obtained CE approval and on the European market nearly one year (as of September, 2013). Registration of EVA for Pharmaceutical and Medical Devices Agency of Japan is being processed. Compared with the current vitrectomy system, EVA is equipped with various innovative features, including high-speed cutter up to 8,000rpm, a new vacuum system (VacuFlow VTi technology), and LED light sources. These new features are supposed to increase EVA's safety, efficiency, and reliability. The purpose of this study is to test EVA's safety, efficiency, and reliability in real clinical situations before its introduction to Japanese Market.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Surgical time for each procedure, complications, and volume of intraocular irrigation at the time of surgery
Key secondary outcomes	Usability of vitrectomy system

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
Interventions/Control_1	Perform primary vitrectomy using a new vitrectomy system EVA, excluidng reoperation.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who are in need of vitrectomy for retinal detachment, epimacular proliferation, macular hole, diabetic retinopathy, or vitreous hemorrhage.
Key exclusion criteria	Patients who does not consent to this study
Target sample size	50

Research contact person
Name of lead principal investigator	Shunji Kusaka
Organization	Sakai Hospital Kinki University Faculty of Medicine
Division name	Department of Ophthalmology
Address	2-7-1 Minami-ku, Sakai, 590-0132, Osaka, JAPAN
TEL	072-299-1120
Email	kusaka-ns@umin.net

Public contact
Name of contact person	Shunji Kusaka
Organization	Sakai Hospital Kinki University Faculty of Medicine
Division name	Department of Ophthalmology
Address	2-7-1 Minami-ku, Sakai, 590-0132, Osaka, JAPAN
TEL	072-299-1120
Homepage URL
Email	kusaka-ns@umin.net

Sponsor
Institute	Kinki University Faculty of Medicine
Institute
Department

Funding Source
Organization	Dutch Ophthalmic Research Center (DORC)
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Holland

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	近畿大学医学部堺病院（大阪府）

Other administrative information
Date of disclosure of the study information	2014 Year 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 01 Day
Anticipated trial start date	2014 Year 01 Month 01 Day
Last follow-up date	2014 Year 04 Month 30 Day
Date of closure to data entry	2014 Year 05 Month 31 Day
Date trial data considered complete	2014 Year 05 Month 31 Day
Date analysis concluded	2014 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Preclinical trial of EVA for vitrectomy was conducted. There were no problems during vitrectomy. EVA seems to be excellent system for vitrectomy.
Other related information

Management information
Registered date	2013 Year 09 Month 22 Day
Last modified on	2016 Year 09 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013833