UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032287 |
|---|---|
| Receipt number | R000036814 |
| Scientific Title | availability assessment of visual dynamic range test on selection of color filter glasses |
| Date of disclosure of the study information | 2018/04/18 |
| Last modified on | 2018/04/17 13:00:07 |
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Basic information
Public title
availability assessment of visual dynamic range test on selection of color filter glasses
Acronym
assessment of visual dynamic range test
Scientific Title
availability assessment of visual dynamic range test on selection of color filter glasses
Scientific Title:Acronym
assessment of visual dynamic range test
Region
| Japan |
Condition
Condition
photophobia
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the availability of 'visual dynamic range test' that can measure easily visual auto gain regulation and dynamic range.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Properties of visual dynamic range (the proportion of pure white and pure black, and the response time) with and without a color filter glasses
Key secondary outcomes
Assessment scores about photophobia, headache and daily behavior, age, sex and causative disease
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
with/without a color filter glasses
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 with a color-filter glasses to reduce the photophobia affecting in their life, and the healthy controls
Key exclusion criteria
persons without understanding about our study plan
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Nakadomari |
Organization
NEXT VISION (a public interest incorporated association)
Division name
NEXT VISION (a public interest incorporated association)
Zip code
Address
2-1-8 Minatojimaminami-machi, Chuo-ku, Kobe-shi, Hyogo
TEL
078-304-4455
satoshin1@mac.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chikako Yamada |
Organization
NEXT VISION (a public interest incorporated association)
Division name
NEXT VISION (a public interest incorporated association)
Zip code
Address
2-1-8 Minatojimaminami-machi, Chuo-ku, Kobe-shi, Hyogo
TEL
078-304-4455
Homepage URL
yamada@nextvision.or.jp
Sponsor or person
Institute
NEXT VISION (a public interest incorporated association)
Institute
Department
Personal name
Funding Source
Organization
Tokaikogaku Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka University, Niigata University, Dokkyo Medical University, The Jikei University School of Medicine, Kobe Eye Center Hospital
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 | 18 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 17 | Day |
Last modified on
| 2018 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036814
