UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038634 |
|---|---|
| Receipt number | R000043705 |
| Scientific Title | Comparison of the eyeblink subjective symptoms and Analysis of the blepharospasm using wearable glasses |
| Date of disclosure of the study information | 2019/11/19 |
| Last modified on | 2019/11/19 16:10:44 |
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Basic information
Public title
Analysis of the blepharospasm using wearable glasses
Acronym
Analysis of the blepharospasm using wearable glasses
Scientific Title
Comparison of the eyeblink subjective symptoms and Analysis of the blepharospasm using wearable glasses
Scientific Title:Acronym
Analysis of the blepharospasm using wearable glasses
Region
| Japan |
Condition
Condition
blepharospasm dryeye
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Subjective symptoms and the medical examination of the blepharospasm often become estranged, and the suit of the patient is not often understood.
The symptom of the dry eye syndrome resembles blepharospasm and may hesitate about a diagnosis.
I study it to be able to analyze the eyeblink objectively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eyeblink test
Shilmer test
Inspection of the dry eye syndrome
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eyesight is good
Understanding is good
Diagnosis of the blepharospasm
Key exclusion criteria
Eyesight is bad
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Gomi |
| Middle name | |
| Last name | Fumi |
Organization
Hyogo College of Medicine Hospital
Division name
Department of ophthalmology,
Zip code
663-8501
Address
1-1mukogawa-cho nisinomiya-shi
TEL
0798-45-6111
ayadaccha0926@gmail.com
Public contact
Name of contact person
| 1st name | Yoshimura |
| Middle name | |
| Last name | ayano |
Organization
Hyogo College of Medicine Hospital
Division name
Department of ophthalmology
Zip code
663-8501
Address
1-1mukogawa-cho nisinomiya-shi
TEL
0798-45-6111
Homepage URL
ayadaccha0926@gmail.com
Sponsor or person
Institute
Hyogo College of Medicine Hospital
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine Hospital
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
Hyogo College of Medicine Hospital
Address
1-1mukogawa-cho nisinomiya-shi
Tel
0798-45-6111
ayadaccha0926@gmail.com
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
| 2019 | Year | 11 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
non
Management information
Registered date
| 2019 | Year | 11 | Month | 19 | Day |
Last modified on
| 2019 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043705
