UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of brilliant blue G in Descemet Membrane Endothelial Keratoplasty
Title of the study (Brief title)	Efficacy of BBG in DMEK
Region	Japan

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

Objectives
Narrative objectives1	In order to achieve proper stain, DMEK surgeons all over the world commonly use trypan blue (TB). However, TB is believed to have a toxic effect on both the cornea and retina. Recently, brilliant blue G (BBG) has been recognized as an alternative for vitreoretinal surgery due to indications of lower levels of toxicity. We prospectively analyze the effect of BBG in DMEK.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Endothelial cell density (ECD): before, 3 months after, 6 months, 1 year after surgery.
Key secondary outcomes	The best spectacle-corrected visual acuity (BSCVA), and central corneal thickness (CCT): before, 3 months after, 6 months, 1 year after surgery.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	The DMEK graft was stained with 0.1% BBG for5 minute and stored in oxyglutathione-containing intraocular irrigation solution until insertion 30 min later.
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 corneal endothelial disease which preoperative visual acuity range from hand motion to 24/20. Iatrogenic bullous keratopathy; after argon laser iridotomy (ALI) , cataract surgery, vitrectomy, or glaucome filtrating surgery. Fuchs corneal endothelial dystrophy. Corneal endotheliopathy caused by pseudoexfoliation syndrome (PEX). Corneal endothelitis. Birth injury.
Key exclusion criteria	Cases in which the patient discontinued consultation during the 6 months of the postoperative follow-up period will be excluded.
Target sample size	50

Research contact person
Name of lead principal investigator	Takahiko Hayashi
Organization	Yokohama Minami Kyosai Hospital
Division name	Department of Ophthalmology
Address	Yokohama Minami Kyosai Hospital, 1-21-1, Mutsuura Higashi, Kanagawa, Yokohama 236-0037, Japan.
TEL	+81-45-787-2101
Email	htakahiko-aikou@umin.ac.jp

Public contact
Name of contact person	Takahiko Hayashi
Organization	Yokohama Minami Kyosai Hospital
Division name	Department of Ophthalmology
Address	Yokohama Minami Kyosai Hospital, 1-21-1, Mutsuura Higashi, Kanagawa, Yokohama 236-0037, Japan.
TEL	+81-45-787-2101
Homepage URL
Email	htakahiko-aikou@umin.ac.jp

Sponsor
Institute	Yokohama Minami Kyosai Hospital
Institute
Department

Funding Source
Organization	none
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 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 01 Day
Anticipated trial start date	2014 Year 08 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://dx.doi.org/10.1155/2017/9720389
Results	Very effective
Other related information

Management information
Registered date	2017 Year 02 Month 26 Day
Last modified on	2018 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030218