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

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 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


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

Value
https://center6.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