UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027586 |
|---|---|
| Receipt number | R000031619 |
| Scientific Title | A prospective study of the outcomes of Descemet membrane endothelial keratoplasty (DMEK) |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2020/07/12 11:07:12 |
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Basic information
Public title
A prospective study of the outcomes of Descemet membrane endothelial keratoplasty (DMEK)
Acronym
A prospective study of Descemet membrane endothelial keratoplasty (DMEK)
Scientific Title
A prospective study of the outcomes of Descemet membrane endothelial keratoplasty (DMEK)
Scientific Title:Acronym
A prospective study of Descemet membrane endothelial keratoplasty (DMEK)
Region
| Japan |
Condition
Condition
Bullous keratopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Descemet membrane endothelial keratoplasty
(DMEK) involving transplantation of only one layer of the endothelium and the thin Descemet membrane, results in quick and excellent improvement in postoperative visual acuity due to less irregularity on the anterior and posterior surfaces of the cornea, and to the very low incidence of post-operative graft rejection. Many ophthalmologists in Europe and the United States have started to perform DMEK in patients with Fuchs corneal endothelial dystrophy. However, it is thought to be a difficult procedure for Asian eyes, which tend to have a shorter axial length, narrower anterior chamber, darkly colored iris, and more advanced corneal edema resulting from various etiologies of bullous keratopathy, compared to Caucasian eyes. A prospective study of the efficacy of DMEK in Asian eye is necessary. BBG 250 (BBG; Sigma-Aldrich, St. Louis, MO, USA) was dissolved in balanced saline solution (BSS or BSS-plus; Alcon, Osaka, Japan) to 0.1% (w/v). All grafts were peeled as described previously. BBG (0.1%, w/v) was used to stain the graft edges during peeling. The donor membrane graft stained with 0.1% (w/v) BBG (1.0 mg/ml) was placed into an intraocular lens injector (model WJ-60M 1 or 2; Santen Pharmaceuticals, Osaka, Japan) and inserted into the anterior chamber. After the donor graft disc was loaded on an intraocular lens inserter (WJ-60M;Santen) with a small amount of OVD(Opegan; Santen) between the graft and the tip of the plunger
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Visual acuity(logMAR),Endothelial Cell Density(ECD), Central Corneal Thickness(CCT),High-order Abberattions(HOAs), and VFQ-25 were assessed preoperatively, and at1,3, 6 months, 1, 2, 3, 4, and 5 years postoperatively.
Key secondary outcomes
Central retinal thickness, Cystoid macula edema(CME), posteior synechia, iris abnormality, operative time, graft unfolding timewere assessed preoperatively, and at1,3, 6 months, 1, 2, 3, 4, and 5 years postoperatively.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Bullous keratopathy, Fuchs endothelial dystrophy, pseudo-exfoliation syndrome, birth injury, corneal endothelitis, eye with low corneal endothelial cell density, because of unknown factors
Key exclusion criteria
patient who dont agree with the research
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takahiko |
| Middle name | |
| Last name | Hayashi |
Organization
Yokohama Minami Kyosai Hospital
Division name
Department of Ophthalmology
Zip code
236-0037
Address
1-21-1 Mutuurahigashi, kanazawa-ku, Yokohama, kanagawa, Japan
TEL
+81457872101
htakahiko-aikou@unim.ac.jp
Public contact
Name of contact person
| 1st name | Takahiko |
| Middle name | |
| Last name | Hayashi |
Organization
Medical Techno
Division name
Department of Ophthalmology
Zip code
2360037
Address
Kanazawa-ku
TEL
+817038502167
Homepage URL
https://www.minamikyousai.jp/
takamed@gmail.com
Sponsor or person
Institute
Department of Ophthalmology, Yokohama Minami Kyosai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama Minami Kyosai Hospital
Address
1-21-1, Mutsuura-Higashi
Tel
+81457872101
takamed@gmail.com
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 | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://journals.lww.com/corneajrnl/Abstract/2018/09000/Double_Bubble_Technique_in_Descemet_Membrane
Publication of results
Partially published
Result
URL related to results and publications
https://journals.lww.com/corneajrnl/Abstract/2018/09000/Double_Bubble_Technique_in_Descemet_Membrane
Number of participants that the trial has enrolled
50
Results
https://journals.lww.com/corneajrnl/Abstract/2018/09000/Double_Bubble_Technique_in_Descemet_Membrane
Results date posted
| 2020 | Year | 07 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
DMEK patients
Participant flow
DMEK patients
Adverse events
Nothing
Outcome measures
BCVA, ECD,rebubbling,graft failure, rejection rates, corneal nerve
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 30 | Day |
Other
Other related information
Prospective, observatiol study
Management information
Registered date
| 2017 | Year | 06 | Month | 01 | Day |
Last modified on
| 2020 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031619
