UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043630 |
|---|---|
| Receipt number | R000049820 |
| Scientific Title | Evaluation of visual function after Descemet membrane endothelial keratoplasty |
| Date of disclosure of the study information | 2021/03/16 |
| Last modified on | 2025/03/19 11:55:41 |
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Basic information
Public title
Evaluation of visual function after Descemet membrane endothelial keratoplasty
Acronym
Evaluation of visual function after Descemet membrane endothelial keratoplasty
Scientific Title
Evaluation of visual function after Descemet membrane endothelial keratoplasty
Scientific Title:Acronym
Evaluation of visual function after Descemet membrane endothelial keratoplasty
Region
| Japan |
Condition
Condition
corneal endothelial cell dysfunction
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
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Corneal endothelial cell count
Key secondary outcomes
visual acuity, corneal topography
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases after Descemet membrane endothelial keratoplasty
Key exclusion criteria
glaucome, retinal disease, systemic disease
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Yamazaki |
Organization
Omiya Nanasato Eye Institute
Division name
Department of Ophthalmology
Zip code
3370017
Address
678-1, Futtono, Minuma Ward, Saitama City, Saitama Prefecture
TEL
0486867000
karamawari@msn.com
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Yamazaki |
Organization
Omiya Nanasato Eye Institute
Division name
Department of Ophthalmology
Zip code
3370017
Address
678-1, Futtono, Minuma Ward, Saitama City, Saitama Prefecture
TEL
0486867000
Homepage URL
karamawari@msn.com
Sponsor or person
Institute
Omiya Nanasato Eye Institute
Institute
Department
Personal name
Funding Source
Organization
Omiya Nanasato Eye Institute
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
Omiya Nanasato Eye Institute
Address
678-1, Futtono, Minuma Ward, Saitama City, Saitama Prefecture
Tel
0486867000
karamawari@msn.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
| 2021 | Year | 03 | Month | 16 | 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
1
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
To analyze data
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation of visual funstion and complication after Descemet membrane endothelial keratoplasty
Management information
Registered date
| 2021 | Year | 03 | Month | 16 | Day |
Last modified on
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049820
