UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Ocular suface observation with anterior optical coherence tomography
Title of the study (Brief title)	Ocular surface observation with AC-OCT
Region	Japan

Condition
Condition	A case with corneal disease A case with post-keratoplasty A case with post-glaucoma operation
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To observe the patients who has corneal disease and taken glaucoma operation with anterior optical coherence tomography
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Corneal thickness Anterior chamber angle
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	To take a picture with anterior OCT for ocular surface disease
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	A case with ocular surface disease A case with post-glaucoma operation
Key exclusion criteria	None
Target sample size	200

Research contact person
Name of lead principal investigator	Tatsuro Miyamoto
Organization	Institute of Biomedical Sciences, Tokushima University Graduate School
Division name	Department of Ophthalmology
Address	3-18-15 Kuramotocho, Tokushima city
TEL	088-633-7163
Email	miyatatsu@tokushima-u.ac.jp

Public contact
Name of contact person	Tatsuro Miyamoto
Organization	Institute of Biomedical Sciences, Tokushima University Graduate School
Division name	Department of Ophthalmology
Address	3-18-15 Kuramotocho, Tokushima city
TEL	088-633-7163
Homepage URL
Email	miyatatsu@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University
Institute
Department

Funding Source
Organization	None
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	2017 Year 08 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 08 Month 01 Day
Anticipated trial start date	2017 Year 08 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

Management information
Registered date	2017 Year 06 Month 08 Day
Last modified on	2017 Year 06 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031723