UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of anterior segment image analysis using Swept Source OCT
Title of the study (Brief title)	Evaluation of anterior segment analysis using SS OCT
Region	Japan

Condition
Condition	glaucoma, corneal dystrophy, leucoma, corneal degeneration, corneal irregular astigmatism, bullous keratopathy, keratoconus, lens disease, post corneal transplantation
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of anterior segment image analysis using Swept Source OCT PLEX elite 9000 (manufactured by Carl Zeiss Meditech), which attached unapproved anterior segment attachment
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	To evaluate the number of taking anterior segment images by using Swept Source OCT and Cirrus 4000 HD-OCT for Anterior chamber depth, Angle opening degree, and Corneal thickness
Key secondary outcomes	correlation with OCT image, visual acuity, intraocular pressure, and Fundus findings

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	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Analyzing images acquired using Swept Source OCT and Cirrus 4000 HD-OCT when the cases are enrolled and images acquired as needed during fifty two weeks from the enrollment of this study
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Those who are visiting or hospitalized at Ophthalmology Department of Shiga Medical University Hospital during this research period 2)Those who have an abnormality in the anterior ocular segment such as cornea, angle, iris 3)Those who can obtain agreement to research participation
Key exclusion criteria	1)Those who might induce epileptic seizures by light stimulation 2)Those who receive photodynamic therapy within forty eight hours
Target sample size	50

Research contact person
Name of lead principal investigator	Takamasa Mori
Organization	Shiga University of Medical Science
Division name	department of opthalmology
Address	Seta-Tsukinowacho, Otsu, Shiga, Japan
TEL	077-548-2276
Email	mrtkms23@belle.shiga-med.ac.jp

Public contact
Name of contact person	Takamasa Mori
Organization	Shiga University of Medical Science
Division name	department of opthalmology
Address	Seta-Tsukinowacho, Otsu, Shiga, Japan
TEL	077-548-2276
Homepage URL
Email	mrtkms23@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Carl Zeiss Meditec, Inc.
Organization
Division
Category of Funding Organization	Profit organization
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	滋賀医科大学医学部付属病院

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 22 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 10 Month 23 Day
Anticipated trial start date	2017 Year 10 Month 23 Day
Last follow-up date	2019 Year 02 Month 28 Day
Date of closure to data entry	2019 Year 02 Month 28 Day
Date trial data considered complete	2019 Year 02 Month 28 Day
Date analysis concluded	2019 Year 02 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 12 Month 21 Day
Last modified on	2019 Year 01 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032637