UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026311 |
|---|---|
| Receipt number | R000030218 |
| Scientific Title | Efficacy of brilliant blue G in Descemet Membrane Endothelial Keratoplasty |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2018/06/03 11:56:24 |
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Basic information
Public title
Efficacy of brilliant blue G in Descemet Membrane Endothelial Keratoplasty
Acronym
Efficacy of BBG in DMEK
Scientific Title
Efficacy of brilliant blue G in Descemet Membrane Endothelial Keratoplasty
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Takahiko Hayashi |
Organization
Yokohama Minami Kyosai Hospital
Division name
Department of Ophthalmology
Zip code
Address
Yokohama Minami Kyosai Hospital, 1-21-1, Mutsuura Higashi, Kanagawa, Yokohama 236-0037, Japan.
TEL
+81-45-787-2101
htakahiko-aikou@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiko Hayashi |
Organization
Yokohama Minami Kyosai Hospital
Division name
Department of Ophthalmology
Zip code
Address
Yokohama Minami Kyosai Hospital, 1-21-1, Mutsuura Higashi, Kanagawa, Yokohama 236-0037, Japan.
TEL
+81-45-787-2101
Homepage URL
htakahiko-aikou@umin.ac.jp
Sponsor or person
Institute
Yokohama Minami Kyosai Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://dx.doi.org/10.1155/2017/9720389
Number of participants that the trial has enrolled
Results
Very effective
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030218
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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