UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060400 |
|---|---|
| Receipt number | R000069093 |
| Scientific Title | A Clinical Review of Corneal Transplantation Cases Performed with a Biopsy Trephine |
| Date of disclosure of the study information | 2026/01/20 |
| Last modified on | 2026/01/18 16:15:22 |
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Basic information
Public title
Corneal Transplantation Performed with a Biopsy Trephine
Acronym
Corneal Transplantation Conducted with a Biopsy Trephine
Scientific Title
A Clinical Review of Corneal Transplantation Cases Performed with a Biopsy Trephine
Scientific Title:Acronym
Evaluation of Corneal Transplantation Using a Biopsy Trephine
Region
| Japan |
Condition
Condition
Corneal perforation, Microcornea
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the surgical outcomes of corneal transplantation performed with a biopsy trephine at Nagasaki University Hospital and to assess its usefulness.
Basic objectives2
Others
Basic objectives -Others
This is expected to lead to expanded indications for corneal transplantation and improved treatment outcomes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Corneal Findings One Year After Corneal Transplantation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent corneal transplantation using a biopsy trephine at the Department of Ophthalmology, Nagasaki University Hospital
Key exclusion criteria
Patients deemed unsuitable as research subjects by researchers.
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Oishi |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Ophthalmology and Visual Science
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
TEL
+81-95-819-7345
akio.oishi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Mao |
| Middle name | |
| Last name | Kusano |
Organization
Nagasaki University Hospital
Division name
Ophthalmology
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
TEL
+81-95-819-7345
Homepage URL
maok@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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
Nagasaki University Hospital Clinical Research Center
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
Tel
+81-95-819-7726
rinshoukenshu@ml.nagasaki-u.ac.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
| 2026 | Year | 01 | Month | 20 | 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
43
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient background, surgical findings, and postoperative course will be collected from the medical records of the target patients, and data analysis will be performed on the surgical findings and postoperative course.
Management information
Registered date
| 2026 | Year | 01 | Month | 18 | Day |
Last modified on
| 2026 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069093
