UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007063 |
|---|---|
| Receipt number | R000008321 |
| Scientific Title | Exploratory clinical trial of artificial cornea Boston keratoprosthesis in eyes with refractory corneal opacity after unsuccessful corneal transplantation |
| Date of disclosure of the study information | 2012/01/13 |
| Last modified on | 2017/07/23 15:05:49 |
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Basic information
Public title
Exploratory clinical trial of artificial cornea Boston keratoprosthesis in eyes with refractory corneal opacity after unsuccessful corneal transplantation
Acronym
Exploratory clinical trial of artificial cornea Boston keratoprosthesis
Scientific Title
Exploratory clinical trial of artificial cornea Boston keratoprosthesis in eyes with refractory corneal opacity after unsuccessful corneal transplantation
Scientific Title:Acronym
Exploratory clinical trial of artificial cornea Boston keratoprosthesis
Region
| Japan |
Condition
Condition
Refractory corneal opacity
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical efficacy and safety of artificial cornea Boston keratoprosthesis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy: visual acuity
Safety: Ratio of KPro survival
Key secondary outcomes
Complications, Adverse effects
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
| Device,equipment |
Interventions/Control_1
Transplantation of Boston KPro
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Eyes after corneal transplant failure over twice in which unsuccessful corneal transplant is expected.
2) Best corrected visual acuity less than 0.05 and visual acuity in the contralateral eye is decreased.
3) Age of 20 years or more.
4) Patients giving informed consent with documents.
Key exclusion criteria
1) End-stage glaucoma
2) Eyes with retinal detachment or optic disc atrophy.
3) Patients with auto-immune disease(pemphigoid, Stevens-Johnson syndrome, uveitis, Sjogren syndrome),after chemical burn, or severe inflammatory disease.
4) Eyes with incomplete blinking or insufficient tearing.
5) Patients who cannot receive frequent postoperative examination.
6) Pregnant women or women who are expected to be pregnant.
7) Breast-feeding women
8) Patients doctors did not think are appropriate for this study.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiko Usui |
Organization
University of Tokyo
Division name
Department of Ophthalmology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-8660
tomohiko-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiko Usui |
Organization
University of Tokyo
Division name
Department of Ophthalmology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-8660
Homepage URL
tomohiko-tky@umin.ac.jp
Sponsor or person
Institute
University of Tokyo Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
None
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
東京大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 13 | 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
| 2011 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | 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
Management information
Registered date
| 2012 | Year | 01 | Month | 13 | Day |
Last modified on
| 2017 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008321
