UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013871 |
|---|---|
| Receipt number | 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 16:21:51 |
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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
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
hide1234@ruby.ocn.ne.jp
Sponsor or person
Institute
Department of ophthalmology, Fukushima medical university school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016178
