UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011366
Receipt number R000012699
Scientific Title Observation of meibomian gland by an infrared camera,Deep Range Imaging optical coherence tomography,and Heidelberg Retinal Tomography and Clarification of meibomian gland dysfunction
Date of disclosure of the study information 2013/09/01
Last modified on 2015/08/03 10:30:48

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Basic information

Public title

Observation of meibomian gland by an infrared camera,Deep Range Imaging optical coherence tomography,and Heidelberg Retinal Tomography and Clarification of meibomian gland dysfunction

Acronym

Observation and Clarification of meibomian gland dysfunction

Scientific Title

Observation of meibomian gland by an infrared camera,Deep Range Imaging optical coherence tomography,and Heidelberg Retinal Tomography and Clarification of meibomian gland dysfunction

Scientific Title:Acronym

Observation and Clarification of meibomian gland dysfunction

Region

Japan


Condition

Condition

meibomian gland dysfunction

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

I observe meibomian gland using digital camera for infrared rays, three-dimensional eyeground imager DRI-OCT Atlantis( Topcon) confocal microscope HRT-II-RCM( Heidelberg), and this study is intended that I examine grasp and the abnormal finding of the anatomical features of meibomian gland and clinical manifestation.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

I examine grasp the healthy region of meibomian glands and morbid change of meibomian glands using digital camera for infrared rays, three-dimensional eyeground imager DRI-OCT Atlantis( Topcon) confocal microscope HRT-II-RCM( Heidelberg)

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

0 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

In a healthy person,it suffers from no ocular surface disease and wear no contact lens.
In an ocular surface disease patient, when undergoing an inspection, it suffers from an ocular surface disease, and about the existence of medical treatment, it is unquestioned.
That from which consent is obtained about participation of this research.

Key exclusion criteria

That whose inspection was not completed.
That from which the consent to this inspection was not obtained.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Maruoka Sachiko

Organization

Saneikai Tsukazaki Hospital

Division name

opthalmology

Zip code


Address

Himeji

TEL

+81-792-72-8555

Email

s.maruoka@tsukazaki-eye.net


Public contact

Name of contact person

1st name
Middle name
Last name Maruoka Sachiko

Organization

Saneikai Tsukazaki Hospital

Division name

opthalmology

Zip code


Address

Himeji Aboshi Waku68-1

TEL

+81-792-72-8555

Homepage URL


Email

s.maruoka@tsukazaki-eye.net


Sponsor or person

Institute

Saneikai Tsukazaki Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

none

Name of secondary funder(s)

none


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

三栄会 ツカザキ病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 01 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

Open public recruiting

Date of protocol fixation

2013 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

I examine grasp the healthy region of meibomian glands and morbid change of meibomian glands using digital camera for infrared rays, three-dimensional eyeground imager DRI-OCT Atlantis( Topcon) confocal microscope HRT-II-RCM( Heidelberg)


Management information

Registered date

2013 Year 08 Month 03 Day

Last modified on

2015 Year 08 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012699


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name