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
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
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
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
