UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036927 |
|---|---|
| Receipt number | R000042078 |
| Scientific Title | Research in contrast sensitivity function test by Accu-pad |
| Date of disclosure of the study information | 2019/06/03 |
| Last modified on | 2019/06/03 00:36:07 |
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Basic information
Public title
Research in contrast sensitivity function test by Accu-pad
Acronym
Research in contrast sensitivity function test by Accu-pad
Scientific Title
Research in contrast sensitivity function test by Accu-pad
Scientific Title:Acronym
Research in contrast sensitivity function test by Accu-pad
Region
| Japan |
Condition
Condition
1.VA of 0.01 logMAR or better and have no history ocular disease other than refractive error
2.Planning cataract surgery have another history ocular disease
3.Had refractive surgery
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of contrast sensitivity function test by Accu-pad
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Contrast sensitivity function
Key secondary outcomes
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
We measure contrast sensitivity by Accu-pad
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
1.VA of 0.01 logMAR or better and have no history ocular disease other than refractive error
2.Planning cataract surgery have another history ocular disease
3.Had refractive surgery
Key exclusion criteria
1.Have disease other than refractive error and cataract
2.Have surgery other than refractive surgery
3.Have corneal disease or amblyopia
4.Have systemic disease such as a diabetes mellitus,multiple sclerosis
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Wakako |
| Middle name | |
| Last name | Ando |
Organization
Kitasato University Hospital
Division name
Ophthalmology
Zip code
252-0374
Address
1-15-1 Kitasato,Mimami-ku,Sagamihara,Kanagawa
TEL
042-778-8111
yui.talahara0422@gmail.com
Public contact
Name of contact person
| 1st name | Yui |
| Middle name | |
| Last name | Takahara |
Organization
Kitasato University Hospital
Division name
Ophthalmology
Zip code
252-0374
Address
1-15-1 Kitasato,Mimami-ku,Sagamihara,Kanagawa
TEL
042-778-8111
Homepage URL
yui.talahara0422@gmail.com
Sponsor or person
Institute
Kitasato University Hospital
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
Kitasato University Hospital
Address
1-15-1 Kitasato,Mimami-ku,Sagamihara,Kanagawa
Tel
042-778-8111
yui-takahara0422@gmail.com
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
| 2019 | Year | 06 | Month | 03 | 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
| 2019 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 03 | Day |
Last modified on
| 2019 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042078
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
