UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014242 |
|---|---|
| Receipt number | R000016591 |
| Scientific Title | Clinical study of Descemet membrane endothelial keratoplasty (DMEK) for patients with bullous keratopathy |
| Date of disclosure of the study information | 2014/06/12 |
| Last modified on | 2016/06/12 13:48:13 |
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Basic information
Public title
Clinical study of Descemet membrane endothelial keratoplasty (DMEK) for patients with bullous keratopathy
Acronym
Clinical study of Descemet membrane endothelial keratoplasty (DMEK) for patients with bullous keratopathy
Scientific Title
Clinical study of Descemet membrane endothelial keratoplasty (DMEK) for patients with bullous keratopathy
Scientific Title:Acronym
Clinical study of Descemet membrane endothelial keratoplasty (DMEK) for patients with bullous keratopathy
Region
| Japan |
Condition
Condition
Bullous keratopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Descemet membrane endothelial keratoplasty (DMEK) for patients with bullous keratopathy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
corneal thickness after surgery
Key secondary outcomes
visual acuity, survival of the graft, corneal endothelial cell density, success in DMEK graft preparation, success in the graft transplantation, complication
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
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Bullous keratopathy patients who are indicated for Endothelial Keratoplasty in Osaka University Hospital
2)Aged 20 years old and over
3)Written informed consent
Key exclusion criteria
1)Bullous keratopathy patients who are not indicated for Endothelial Keratoplasty
2)Those who have been decided not appropriate for enrollment by the principal investigator.
3)Patients of less than 6 months follow-up period.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kohji Nishida |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3451
knishida@ophthal.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Soma |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3456
Homepage URL
soma@ophthal.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
大阪大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 12 | 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
| 2014 | Year | 06 | Month | 12 | Day |
Last modified on
| 2016 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016591
