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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028164
Receipt No. R000032238
Scientific Title A study on objective findings and subjective symptoms in asthenopia after VDT work
Date of disclosure of the study information 2017/07/11
Last modified on 2018/01/09

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Basic information
Public title A study on objective findings and subjective symptoms in asthenopia after VDT work
Acronym A study on asthenopia after VDT work
Scientific Title A study on objective findings and subjective symptoms in asthenopia after VDT work
Scientific Title:Acronym A study on asthenopia after VDT work
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the relationship between subjective symptoms and objective findings of asthenopia after VDT work
Basic objectives2 Others
Basic objectives -Others Correlation between the differences of the accommodative microfluctuation (HFC67cm) value and the VAS value in the morning and the evening
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Correlation between the differences of the accommodative microfluctuation (HFC67cm) value and the VAS value in the morning and the evening
Key secondary outcomes 1. Correlation between the differences of the value of HFC1
, HFC2 and the average of HFC value and the VAS value in the morning and the evening
2. Changes of HFC 1, HFC 67 cm, HFC 2, the average of HFC value (HFC parameters) in the morning and evening
3. Presence or absence of background factors affecting changes of HFC parameters in the morning and evening

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Measurement of accomdative microfluctuation value by ARK 560 A
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 Healty adult and person who agreed to participate in this research
Key exclusion criteria 1. A person with myopia exceeding -6 D
2. A person with hyperopia
3. A person who is taking measures against presbyopia (use of reading glasses or bifocal glasses, always removing eyeglasses for VDT work, etc)
4. People who have undergone surgery of LASIK
5. Person who is aware of intense astigmatism
6. Person who is inserting multifocal intraocular lens
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshihide Suenobu
Organization Senju Pharmaceutical Co., Ltd
Division name Medical Science Department, Research & Development Division
Zip code
Address 2-5-8 Hiranomachi, Chuo-ku, Osaka Japan
TEL 06-6201-2552
Email t-suenobu@senju.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Futoshi Miyamoto
Organization Senju Pharmaceutical Co., Ltd.
Division name Clinical Resarch Management Group,
Zip code
Address 2-5-8 Hiranomachi, Chuo-ku, Osaka Japan
TEL 06-6201-2552
Homepage URL
Email f-miyamoto@senju.co.jp

Sponsor
Institute Senju Pharmaceutical Co., Ltd.
Clinical Resarch Management Group,
Institute
Department

Funding Source
Organization Senju Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 千寿製薬株式会社

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 11 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
2017 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 24 Day
Last follow-up date
2017 Year 10 Month 06 Day
Date of closure to data entry
2017 Year 10 Month 06 Day
Date trial data considered complete
2017 Year 11 Month 09 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 07 Month 10 Day
Last modified on
2018 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032238

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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