UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009487 |
|---|---|
| Receipt number | R000011148 |
| Scientific Title | Analysis of Eyes Undergone Boston Keratoprosthesis transplantation Using Anterior Segment Optical Coherence Tomography |
| Date of disclosure of the study information | 2012/12/05 |
| Last modified on | 2012/12/05 23:55:51 |
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Basic information
Public title
Analysis of Eyes Undergone Boston Keratoprosthesis transplantation Using Anterior Segment Optical Coherence Tomography
Acronym
Analysis of Boston Keratoprosthesis transplantation Using Anterior Segment Optical Coherence Tomography
Scientific Title
Analysis of Eyes Undergone Boston Keratoprosthesis transplantation Using Anterior Segment Optical Coherence Tomography
Scientific Title:Acronym
Analysis of Boston Keratoprosthesis transplantation Using Anterior Segment Optical Coherence Tomography
Region
| Japan |
Condition
Condition
Eyes that had Boston Keratoprosthesis (KPro) transplantation
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study anatomical status of eyes that had Boston Keratoprosthesis (KPro) transplantation using anterior segment optical coherence tomography (AS-OCT).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual acurity, OCT
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
Eyes Undergone Boston Keratoprosthesis transplantation
Key exclusion criteria
None
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yumiko Hirayama |
Organization
Ichikawa General Hospital Toyko Dental Collage
Division name
Ophthalmology
Zip code
Address
5-11-13 Sugano, Ichikawa, Chiba
TEL
(047)322-0151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Ichikawa General Hospital Toyko Dental Collage
Division name
Ophthalmology
Zip code
Address
TEL
Homepage URL
tamayumi@me.com
Sponsor or person
Institute
Ichikawa General Hospital Toyko Dental Collage
Institute
Department
Personal name
Funding Source
Organization
Ichikawa General Hospital Toyko Dental Collage
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
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
| 2012 | Year | 12 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We evaluated anatomical relationship between KPro and corneal grafts, fibrous membrane formation, and depth of the anterior chamber using AS-OCT.
Management information
Registered date
| 2012 | Year | 12 | Month | 05 | Day |
Last modified on
| 2012 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011148
