UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Corneal endothelial staining by VisionBlue during DMEK surgery
Title of the study (Brief title)	Corneal endothelial staining by VisionBlue
Region	Japan

Condition
Condition	Bullous keratopathy
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	safety of VisionBlue during DMEK surgery
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	postoperative visual acuity (1W)
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver Other
Interventions/Control_1	endothelial sheet was stained by Visoin Blue for 1min during DMEK surgery
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	Patients with Bullous keratopathy who was planned to have corneal endothelial transplantation
Key exclusion criteria	Patients whom attending doctor decide as unsuitable for DMEK surgery
Target sample size	10

Research contact person
Name of lead principal investigator	Tetsuya Kawakita
Organization	Keio University School of Medicine
Division name	Ophthalmology
Address	35, Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	kawakita@a2.keio.jp

Public contact
Name of contact person	Tetsuya Kawakita
Organization	Keio Univ. School of Medicine
Division name	Ophthalmology
Address	35, Shinanomachi, Shinjuku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	kawakita@a2.keio.jp

Sponsor
Institute	Department of ophthalmology, Keio University School of Medicine
Institute
Department

Funding Source
Organization	Department of ophthalmology, Keio University School of Medicine
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

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 05 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 10 Month 01 Day
Anticipated trial start date	2016 Year 01 Month 10 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	2015 Year 12 Month 17 Day
Last modified on	2019 Year 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023385