UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility assessment of intraoperative endoillumination with controlled spectral distribution.
Title of the study (Brief title)	Feasibility assessment of intraoperative endoillumination with controlled spectral distribution.
Region	Japan

Condition
Condition	vitreoretinal diseases (epiretinal membrane, macular hole, diabetic retinopathy, retinal detachment, retinal hemorrhage)
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess visibility of retinal lesions using endoillumination with controlled spectral distribution during surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	rate of intraoperative complication
Key secondary outcomes	visibility of retinal lesion

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	use endoillumination with control spectral distribution light source for about 5 minuits per surgery.
Interventions/Control_2	use endoillumination with usual light source
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	one who will receive vitreoretinal surgery
Key exclusion criteria	one without consent
Target sample size	20

Research contact person
Name of lead principal investigator	Sujin Hoshi
Organization	Faculty of Medicine, University of Tsukuba
Division name	Ophthalmology
Address	1-1-1 Tennoudai, Tsukuba-city, Ibaraki, Japan
TEL	029-853-3148
Email	hoshisujin@md.tsukuba.ac.jp

Public contact
Name of contact person	Sujin Hoshi
Organization	Faculty of Medicine, University of Tsukuba
Division name	Ophthalmology
Address	1-1-1 Tennoudai, Tsukuba-city, Ibaraki, Japan
TEL	029-853-3148
Homepage URL
Email	hoshisujin@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	University of Tsukuba
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 11 Month 01 Day
Anticipated trial start date	2017 Year 12 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	2017 Year 10 Month 26 Day
Last modified on	2017 Year 10 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033962