UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020252 |
|---|---|
| Receipt number | R000023383 |
| Scientific Title | Evaluation of cornea preserved by CAS system |
| Date of disclosure of the study information | 2015/12/20 |
| Last modified on | 2018/04/02 07:45:25 |
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Basic information
Public title
Evaluation of cornea preserved by CAS system
Acronym
Evaluation of cornea preserved by CAS system
Scientific Title
Evaluation of cornea preserved by CAS system
Scientific Title:Acronym
Evaluation of cornea preserved by CAS system
Region
| Japan |
Condition
Condition
Diseases which need preserved corneal transplantation
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare post operative corneal endothelial density and corneal edema between conventional preserved cornea and CAS-preserved cornea
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative evaluation (1, 3 and 12M)
1. Fluorescein corneal staining
2. stromal cell density
3. endothelial cell density
Key secondary outcomes
Visual acuity, corneal edema and thickness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Cryopreserved methodology pf cornea
(CAS system)
Interventions/Control_2
Conventional cryopreserved cornea
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
Patients which was diagnosed to be neccesarry to have cryp-preserved corneal transplantation by ophthalmologist
Key exclusion criteria
1. Patients who cannot afford to have ophthalmic examination
2. Patients who cannot afford CAS-preserved corneal transplantation
3. patients who have severe anuto-immune diseases and/or systemic diseases which affect corneal status
4. Patients who had ocular surface surgery within 3months
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Kawakita |
Organization
Keio University School of Medicine
Division name
Ophthalmology
Zip code
Address
35, Shinanomachi, Shinjuku, Tokyo
TEL
03-3353-1211
kawakita@a2.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Kawakita |
Organization
Keio University School of Medicine
Division name
Ophthalmology
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-3353-1211
Homepage URL
kawatetsu@gmail.com
Sponsor or person
Institute
Department of Ophthalmology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Address
Tel
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
| 2015 | Year | 12 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 17 | Day |
Last modified on
| 2018 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023383
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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