UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021104 |
|---|---|
| Receipt number | R000024351 |
| Scientific Title | Retrospective study of corneal transplatation |
| Date of disclosure of the study information | 2016/02/19 |
| Last modified on | 2020/12/10 10:40:31 |
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Basic information
Public title
Retrospective study of corneal transplatation
Acronym
Retrospective study of corneal transplatation
Scientific Title
Retrospective study of corneal transplatation
Scientific Title:Acronym
Retrospective study of corneal transplatation
Region
| Japan |
Condition
Condition
Post corneal graft transplantation eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of post operative status of corneal transplantation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Corneal graft survival
Key secondary outcomes
Visual acuity, Corneal endothelial density, Central corneal thickness
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
Post corneal transplantation
Key exclusion criteria
Patients who disagree to be involved in the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Wakimasu |
Organization
Baptist Eye Yamasaki Clinic
Division name
Ophthalmology
Zip code
606-8287
Address
12 Kamiikedacho Kitashirakawa Sakyoku Kyoto, Japan
TEL
075-721-3800
kwakimas@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Wakimasu |
Organization
Baptist Eye Yamasaki Clinic
Division name
Ophthalmology
Zip code
606-8287
Address
12 Kamiikedacho Kitashirakawa Sakyoku Kyoto, Japan
TEL
075-721-3800
Homepage URL
kwakimas@koto.kpu-m.ac.jp
Sponsor or person
Institute
Baptist Eye Yamasaki Clinic
Institute
Department
Personal name
Funding Source
Organization
Baptist Eye Yamasaki Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Baptist Eye Yamasaki Clinic
Address
12 Kamiikedacho Kitashirakawa Sakyoku Kyoto, Japan
Tel
075-721-3800
secret@eye-clinic.gr.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2012 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2012 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2016 | Year | 02 | Month | 19 | Day |
Last modified on
| 2020 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024351
