UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031137 |
|---|---|
| Receipt number | R000035512 |
| Scientific Title | Evaluation of effectivness of the Eyelid clamper |
| Date of disclosure of the study information | 2018/02/07 |
| Last modified on | 2018/07/17 11:06:21 |
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Basic information
Public title
Evaluation of effectivness of the Eyelid clamper
Acronym
Evaluation of effectivness of the Eyelid clamper
Scientific Title
Evaluation of effectivness of the Eyelid clamper
Scientific Title:Acronym
Evaluation of effectivness of the Eyelid clamper
Region
| Japan |
Condition
Condition
retinal disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of using Eyelidclamper while aquiring retinal image by the optos
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
area of the retina imaged using Eyelid clamper and optos
Key secondary outcomes
marginal reflex distance while applying the Eyelid clamper
corneal change after using Eyelid clamper
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients who visit Keio University Hospital ophthalmology department
Key exclusion criteria
corneal disease
patient who had eye surgery within 6 months
active infectious inflammation
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihide Kurihara |
Organization
Keio University
Division name
School of Medicine, Department of Ophthalmology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
kurihara@z8.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuhiro Ozawa |
Organization
Keio University
Division name
School of Medicine, Department of Ophthalmology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
n.ozw@z5.keio.jp
Sponsor or person
Institute
Keio University
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
YES
Study ID_1
20170235
Org. issuing International ID_1
Keio University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 07 | 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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
area of retinal image acquired by the Optos
Management information
Registered date
| 2018 | Year | 02 | Month | 04 | Day |
Last modified on
| 2018 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035512
