UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032385 |
|---|---|
| Receipt number | R000036934 |
| Scientific Title | Comparison of kinetic visual acuity and night visual acuity in monocular and binocular vision |
| Date of disclosure of the study information | 2018/04/26 |
| Last modified on | 2018/12/20 15:28:10 |
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Basic information
Public title
Comparison of kinetic visual acuity and night visual acuity in monocular and binocular vision
Acronym
Comparison of kinetic visual acuity and night visual acuity in monocular and binocular vision
Scientific Title
Comparison of kinetic visual acuity and night visual acuity in monocular and binocular vision
Scientific Title:Acronym
Comparison of kinetic visual acuity and night visual acuity in monocular and binocular vision
Region
| Japan |
Condition
Condition
Normal volunteer
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare kinetic visual acuity and night visual acuity in monocular and binocular vision.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
kinetic visual acuity and night visual acuity
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
#20 years old and over
#No systemic diseases or eye diseases affecting visual function, no history of surgery
#There is no history of refractive surgery
Key exclusion criteria
#The best corrected visual acuity of both eyes is (0.7) or over
#The score of MMSE is less than 24 points (MMSE: Mini-Mental State Examination )
#Abnormal stereovision
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuno Negishi |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo 1608582, Japan
TEL
03-5363-3821
kazunonegishi@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuno Negishi |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo 1608582, Japan
TEL
03-5363-3821
Homepage URL
kazunonegishi@keio.jp
Sponsor or person
Institute
Department of Ophthalmology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hitachi Automotive Systems, Ltd.
Hitachi, Ltd.
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
| 2018 | Year | 04 | Month | 26 | 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 | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary outcomes: Kinetic visual acuity and night vision acuity.
Management information
Registered date
| 2018 | Year | 04 | Month | 26 | Day |
Last modified on
| 2018 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036934
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/09/06 | 研究計画書_動体視力夜間視力.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
