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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013871
Receipt No. R000016178
Scientific Title Study of the tear secretion's function with new strip meniscometry tube part 1: Influence of visual field test to tear film and ocular surface
Date of disclosure of the study information 2014/05/10
Last modified on 2019/05/31

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Basic information
Public title Study of the tear secretion's function with new strip meniscometry tube part 1: Influence of visual field test to tear film and ocular surface
Acronym Influence of visual field test to tear film and ocular surface
Scientific Title Study of the tear secretion's function with new strip meniscometry tube part 1: Influence of visual field test to tear film and ocular surface
Scientific Title:Acronym Influence of visual field test to tear film and ocular surface
Region
Japan

Condition
Condition glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the influence of visual field test to tear film and ocular surface
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Examination of tear with strip meniscometry tube
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
10 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Glaucoma patients who need visual field test
Key exclusion criteria The patients who do not wish the test
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Tetuju
Middle name
Last name Sekiryu
Organization Fukushima medical university school of medicine
Division name department of ophthalmology
Zip code 960-1295
Address 1 Hikariga-oka, Fukushima City, Fukushima Prefecture 960-1295, Japan.
TEL 024-547-1111
Email sekiryu@fmu.ac.jp

Public contact
Name of contact person
1st name Hideto
Middle name
Last name Sagara
Organization Marui Eye Clinic
Division name Director
Zip code 975-0062
Address 1-83-3, Honjinmae Haramachi-ku, Minamisouma City, Fukushima Prefecture 975-0062, Japan
TEL 0244-24-0101
Homepage URL
Email hide1234@ruby.ocn.ne.jp

Sponsor
Institute Department of ophthalmology, Fukushima medical university school of medicine
Institute
Department

Funding Source
Organization Marui Eye Clinic
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Marui Eye Clinic
Address 1-83-3, Honjinmae Haramachi, Minamisoma, Fukushima 975-0062, Japan
Tel +81 244 24 0101
Email hide1234@ruby.ocn.ne.jp

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
2014 Year 05 Month 10 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
2014 Year 05 Month 02 Day
Date of IRB
2014 Year 04 Month 01 Day
Anticipated trial start date
2014 Year 05 Month 07 Day
Last follow-up date
2018 Year 01 Month 28 Day
Date of closure to data entry
2019 Year 05 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information We check the amount of tear with strip meniscometry tube before and after visual fild test.

Management information
Registered date
2014 Year 05 Month 02 Day
Last modified on
2019 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016178

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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