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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000021478
Receipt No. 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 2018/12/22

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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
Middle name
Last name Yu Monden
Organization Kurume University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 67 Asahi-machi, Kurume 830-0011, Japan.
TEL 0942-31-7574
Email you@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yu Monden
Organization Kurume University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 67 Asahi-machi, Kurume 830-0011, Japan.
TEL 0942-31-7574
Homepage URL
Email kurumeye@med.kurume-u.ac.jp

Sponsor
Institute Kurume University
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2016 Year 02 Month 16 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 17 Day
Last follow-up date
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
2018 Year 12 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024775

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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