UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observation of Meibomian gland morphology with infrared rays
Title of the study (Brief title)	Observation of Meibomian gland with infrared rays
Region	Japan

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

Objectives
Narrative objectives1	examination of the relationship between various cause of dry eye and meibomian gland morphology
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	disappear, shortening and variation of the meibomian glands
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	5 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Inclusion criteria included an ability to understand the trial procedures, and, thus, the ability to provide informed consent.
Key exclusion criteria	Exclusion criteria included an inability to understand the trial procedures, and, thus, the inability to provide informed consent.
Target sample size	500

Research contact person
Name of lead principal investigator	Tetuju Sekiryu
Organization	Fukushima medical university school of medicine
Division name	department of ophthalmology
Address	1 Hikariga-oka, Fukushima City, Fukushima Prefecture 960-1295, Japan.
TEL	024-547-1111
Email	sekiryu@fmu.ac.jp

Public contact
Name of contact person	Sagara Hideto
Organization	Marui Eye Clinic
Division name	director
Address	1-83-3, Honjinmae Haramachi-ku, Minamisouma City, Fukushima Prefecture 975-0062, Japan
TEL	0244-24-0101
Homepage URL
Email	hide1234@ruby.ocn.ne.jp

Sponsor
Institute	department of ophthalmology, Fukushima medical university school of medicine
Institute
Department

Funding Source
Organization	department of ophthalmology, Fukushima medical university school of medicine, Maru Eye Clinic
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2012 Year 08 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 03 Month 01 Day
Anticipated trial start date	2011 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We observe meibomian glands with noncontact device using infrared rays at the same time with a medical examination. And, we evaluate the morphology of the meibomian glands and use the aquired data to diagnose the dry eye.

Management information
Registered date	2012 Year 08 Month 21 Day
Last modified on	2018 Year 08 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010247