UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015070 |
|---|---|
| Receipt number | R000017491 |
| Scientific Title | The new guidline of corneal transplantation based on the inflammatory Cytokines in the Tears. |
| Date of disclosure of the study information | 2014/09/05 |
| Last modified on | 2014/09/05 17:47:44 |
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Basic information
Public title
The new guidline of corneal transplantation based on the inflammatory Cytokines in the Tears.
Acronym
The relation of the inflammatory Cytokines in the tears to the conreal tarnsplantation
Scientific Title
The new guidline of corneal transplantation based on the inflammatory Cytokines in the Tears.
Scientific Title:Acronym
The relation of the inflammatory Cytokines in the tears to the conreal tarnsplantation
Region
| Japan |
Condition
Condition
eyes that have candidate for the corneal transplantation
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the change of the inflammatory cytokines in the tears after the corneal transplantation over time
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
to evaluate the inflammatory Cytokines (IL-1alpha,IL-1beta,IL-2,IL-4,IL-6,IL-8,IL-17A,TNF) in the Tears. Corneal thickness
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Penetrating Keratoplasty
Interventions/Control_2
Descemet's stripping automated endothelial keratoplasty
Interventions/Control_3
Deep Anterior Lamellar Keratoplasty
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Normal eyes and eyes after keratoplasty
Key exclusion criteria
The exclusion criteria included limbal stem cell deficiency or previous glaucoma and corneal transplantatioin surgery.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Tomida |
Organization
Tokyo Dental College Ichikawa General Hospital
Division name
Ophthalmology
Zip code
Address
5-11-13, Sugano, Ichikawa, Chiba, Japan
TEL
047-322-0151
dee_tomida@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Tomida |
Organization
Tokyo Dental College Ichikawa General Hospital
Division name
Ophthalmology
Zip code
Address
5-11-13, Sugano, Ichikawa, Chiba, Japan
TEL
047-322-0151
Homepage URL
dee_tomida@yahoo.co.jp
Sponsor or person
Institute
Tokyo Dental College
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2014 | Year | 09 | Month | 05 | 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
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 31 | 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
| 2014 | Year | 09 | Month | 05 | Day |
Last modified on
| 2014 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017491
| 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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