UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028164 |
|---|---|
| Receipt number | 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 10:15:27 |
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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
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
f-miyamoto@senju.co.jp
Sponsor or person
Institute
Senju Pharmaceutical Co., Ltd.
Clinical Resarch Management Group,
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032238
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
