UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041654 |
|---|---|
| Receipt number | R000047546 |
| Scientific Title | Evaluation of immune cells on corneal endothelium of the transplanted cornea |
| Date of disclosure of the study information | 2020/09/03 |
| Last modified on | 2021/04/17 14:36:14 |
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Basic information
Public title
Evaluation of immune cells on corneal endothelium of the transplanted cornea
Acronym
Evaluation of immune cells on corneal endothelium of the transplanted cornea
Scientific Title
Evaluation of immune cells on corneal endothelium of the transplanted cornea
Scientific Title:Acronym
Evaluation of immune cells on corneal endothelium of the transplanted cornea
Region
| Japan | Asia(except Japan) |
Condition
Condition
Post keratoplasty
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of immune cells on graft
Basic objectives2
Others
Basic objectives -Others
The association between the corneal endothelial cell density, type of keratoplasty, aqueous flare, repeated keratoplasty, or time after surgery to density of immune cells will be investigated.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Density of immune cells
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Post keratoplasty and post cataract surgery
Key exclusion criteria
Active ocular inflammation and use of systemic immune suppressive drugs
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Okumura |
Organization
Doshisha University
Division name
Department of Biomedical Engineering
Zip code
610-0321
Address
1-3 Tatara-miyakodani Kyotanabe
TEL
0774-65-6508
nokumura@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Okumura |
Organization
Doshisha University
Division name
Department of Biomedical Engineering
Zip code
610-0321
Address
1-3 Tatara-miyakodani Kyotanabe
TEL
0774-65-6508
Homepage URL
nokumura@mail.doshisha.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Doshisha University Ethics Committee for Scientific Research Involving Human Subjects
Address
1-3 Tatara-miyakodani Kyotanabe
Tel
075-251-3158
ji-rinri@mail.doshisha.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
Study Code 841-2019-P
Org. issuing International ID_1
Sankara Nethralaya
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 03 | 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
90
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
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2020 | Year | 09 | Month | 02 | Day |
Last modified on
| 2021 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047546
