UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021435 |
|---|---|
| Receipt number | R000024725 |
| Scientific Title | Development of eye treatment method using amniotic membrane |
| Date of disclosure of the study information | 2016/03/11 |
| Last modified on | 2016/09/16 09:53:22 |
* 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
Development of eye treatment method using amniotic membrane
Acronym
Treatment using amniotic membrane
Scientific Title
Development of eye treatment method using amniotic membrane
Scientific Title:Acronym
Treatment using amniotic membrane
Region
| Japan |
Condition
Condition
Corneal scleral perforation, Infectious keratoconjunctivitis, Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of development and effectiveness of the new technique the clinical effects are expected
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amniotic menbrane is expected utility as instead of the corneal donor
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
It is scheduled to undergo a Caesarean section at Tohoku University Hospital,who was to give a consent to this study.
Key exclusion criteria
Minor
Adult who does not have sufficient judgment
Unconscious adult person
Adult's attention must be paid to the disease name
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunji Yokokura |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1-2 Seiryocho Aobaku Sendai Miyagi
TEL
022-717-7294
yokokura@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunji Yokokura |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1-2 Seiryocho Aobaku Sendai Miyagi
TEL
022-717-7294
Homepage URL
yokokura@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Ophthalmology and Visual Science, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology and Visual Science, Tohoku University Graduate School of Medicine
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
| 2016 | Year | 03 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 03 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Recruitment methods of the subject (on top of the hospitalization at our facility, is scheduled to undergo a Caesarean section, meet the selection criteria, cases of consent)
The amniotic membrane is not risk for a tissue that is normally discarded during the Caesarean section, there is no privacy problems such for performing the coupling impossible anonymization.
Management information
Registered date
| 2016 | Year | 03 | Month | 11 | Day |
Last modified on
| 2016 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024725
