UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026734
Receipt number R000030690
Scientific Title Investigation of the effect on lidskin and ocular surface by Er:YAG and Nd:YAG Laser
Date of disclosure of the study information 2017/03/28
Last modified on 2018/03/15 10:19:24

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Basic information

Public title

Investigation of the effect on lidskin and ocular surface by Er:YAG and Nd:YAG Laser

Acronym

the effect on lidskin and ocular surface by Er:YAG and Nd:YAG Laser

Scientific Title

Investigation of the effect on lidskin and ocular surface by Er:YAG and Nd:YAG Laser

Scientific Title:Acronym

the effect on lidskin and ocular surface by Er:YAG and Nd:YAG Laser

Region

Japan


Condition

Condition

bags under eyes

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate of the effect on eyelid and ocular surface by Er;YAG and Nd:YAG laser

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

bags under eye

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

Er:YAG and Nd:YAG laser

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

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

people who have bags under eyes

Key exclusion criteria

people who cannot visit on designated date
people who are under treatment of ocular disease or systemic disease
people who cannot take out contact lens and take makeup off on investigation days

Target sample size

20


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 or person

Institute

Haneginomori Eye Clinic

Institute

Department

Personal name



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

2017 Year 03 Month 28 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 02 Month 28 Day

Date of IRB


Anticipated trial start date

2017 Year 03 Month 28 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

2017 Year 03 Month 28 Day

Last modified on

2018 Year 03 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030690


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name