UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032287
Receipt No. 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

* 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 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
Email 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
Email yamada@nextvision.or.jp

Sponsor
Institute NEXT VISION (a public interest incorporated association)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036814

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.