UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033057 |
|---|---|
| Receipt number | R000037681 |
| Scientific Title | To investigate of corneal transplantation using imported cornea (Penetrating Keratoplasty & Deep Anterior Lamellar Keratoplasty & Anterior Lamellar Keratoplasty & Endothelial Keratoplasty) |
| Date of disclosure of the study information | 2018/06/20 |
| Last modified on | 2019/07/08 17:14:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
To investigate of corneal transplantation using imported cornea (Penetrating Keratoplasty & Deep Anterior Lamellar Keratoplasty & Anterior Lamellar Keratoplasty & Endothelial Keratoplasty)
Acronym
To investigate of corneal transplantation using imported cornea
Scientific Title
To investigate of corneal transplantation using imported cornea (Penetrating Keratoplasty & Deep Anterior Lamellar Keratoplasty & Anterior Lamellar Keratoplasty & Endothelial Keratoplasty)
Scientific Title:Acronym
To investigate of corneal transplantation using imported cornea
Region
| Japan |
Condition
Condition
Bullous keratopathy,Corneal opacity,corneal perforation,keratoconus etc
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluation on safety of keratoplasty using imported cornea
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
analysis of the shape of A cornea using anterior segment optical coherence tomography of 1 month after surgery
Key secondary outcomes
endothelial cell density 1 month after surgery
Perioperative bacteriological inspection
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
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patient who needs the keratoplasty including bullous keratopathy, corneal opacity, corneal perforation, keratoconus and the other
The patient that visual acuity will be expected to recover by keratoplasty
The patient that it was understood enough after having received enough explanation, and a document agreement by the free will of a patient was provided.
Key exclusion criteria
The patient who can expect recovery of the visual acuity by a therapeutic method except the keratoplasty.
The patient have a disease that treatment is more necessary than doing keratoplasty.
The patient won't gain the benefit for ophthalmic operation by other diseases.
The patient that during the pregnancy or the pregnancy became clear.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Mastuzawa |
Organization
Kawasaki Municipal Tama hospital
Division name
Ophthalmology
Zip code
2148525
Address
1-30-37, Shukugawara, Tama-ku, Kawasaki-shi, Kanagawa
TEL
044-933-8111
matuzo3a@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Mastuzawa |
Organization
Kawasaki Municipal Tama hospital
Division name
Ophthalmology
Zip code
2148525
Address
1-30-37, Shukugawara, Tama-ku, Kawasaki-shi, Kanagawa
TEL
0449338111
Homepage URL
matuzo3a@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Municipal Tama hospital
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
St.Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa
Tel
0449778111
matuzo3a@marianna-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
| 2018 | Year | 06 | 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
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
| 2015 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 19 | Day |
Last modified on
| 2019 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037681
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
