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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030926
Receipt No. R000035229
Scientific Title Evaluation of LED low-level phototherapy (LED-LLLT) for Meibomian gland dysfunction
Date of disclosure of the study information 2018/01/22
Last modified on 2018/03/15

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Basic information
Public title Evaluation of LED low-level phototherapy (LED-LLLT) for Meibomian gland dysfunction
Acronym Evaluation of LED low-level phototherapy (LED-LLLT) for Meibomian gland dysfunction
Scientific Title Evaluation of LED low-level phototherapy (LED-LLLT) for Meibomian gland dysfunction
Scientific Title:Acronym Evaluation of LED low-level phototherapy (LED-LLLT) for Meibomian gland dysfunction
Region
Japan

Condition
Condition meibomian gland dysfunction
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Perform LED-LLLT using Lutronic HEALITE II. After that, we examined the effect of Meibomian gland dysfunction and the effects of around the eye tissues and ocular surface findings, as well as the effect of ocular surface and safety on treatment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Phase I

Assessment
Primary outcomes Meibum ( evalution of Lipid from meibomian gland), lid margin evaluation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 LED-Low Level Light Therapy
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
70 years-old >=
Gender Male and Female
Key inclusion criteria People who was diagnosed with meibomian gland dysfunction with subjective symptom of dry eye
Key exclusion criteria people who cannot visit on designated date
people who are under treatment of ocular disease or systemic disease
People with a tattoo
people who cannot take out contact lens and take makeup off on investigation days
Pregnant, lactating woman
people who are claustrophobia
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoko Kawashima
Organization Haneginomori Eye Clinic
Division name Ophthalmology
Zip code
Address 4-26-4 daita, Setakaga-ku, Tokyo, Japan
TEL 03-6265-8777
Email motoko326@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Motoko Kawashima
Organization Haneginomori Eye Clinic
Division name Ophthalmology
Zip code
Address 4-26-4 daita, Setakaga-ku, Tokyo, Japan
TEL 03-6265-8777
Homepage URL
Email motoko326@gmail.com

Sponsor
Institute Haneginomori Eye Clinic
Institute
Department

Funding Source
Organization Haneginomori Eye Clinic
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 01 Month 22 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 03 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 22 Day
Last modified on
2018 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035229

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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