UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021478 |
|---|---|
| Receipt number | R000024775 |
| Scientific Title | Efficacy and safety of Descemet membrane endothelial keratoplasty (DMEK) for bullous keratopathy |
| Date of disclosure of the study information | 2016/03/17 |
| Last modified on | 2021/10/19 14:10:46 |
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Basic information
Public title
Efficacy and safety of Descemet membrane endothelial keratoplasty (DMEK) for bullous keratopathy
Acronym
Evaluation of Descemet membrane endothelial keratoplasty (DMEK)
Scientific Title
Efficacy and safety of Descemet membrane endothelial keratoplasty (DMEK) for bullous keratopathy
Scientific Title:Acronym
Evaluation 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
To evaluate efficacy and safety of Descemet membrane endothelial keratoplasty (DMEK).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Visual acuity
Key secondary outcomes
Keratometry
Endothelial cell density
Pachymetry
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 |
Interventions/Control_1
Descemet membrane endothelial keratoplasty (DMEK)
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
Key exclusion criteria
Aphakia
Severe corneal stromal opacity
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Monden |
Organization
Kurume University School of Medicine
Division name
Department of Ophthalmology
Zip code
830-0011
Address
67 Asahi-machi, Kurume 830-0011, Japan.
TEL
0942317574
you@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Monden |
Organization
Kurume University School of Medicine
Division name
Department of Ophthalmology
Zip code
830-0011
Address
67 Asahi-machi, Kurume 830-0011, Japan.
TEL
0942317574
Homepage URL
you@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
Kurume University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Kurume University Hospital
Address
67 Asahi-machi, Kurume 830-0011, Japan.
Tel
0942-31-7200
i_rinri@kurume-u.ac.jp
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
久留米大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Terminated
Date of protocol fixation
| 2016 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 15 | Day |
Last modified on
| 2021 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024775
