UMIN-CTR Clinical Trial

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
Email	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
Email	ayadaccha0926@gmail.com

Sponsor
Institute	Hyogo College of Medicine Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043705