UMIN-CTR Clinical Trial

Basic information
Public title	Fundus imaging using Swept-source optical coherence tomography (OCT)
Acronym	Fundus imaging using Swept-source optical coherence tomography (OCT)
Scientific Title	Fundus imaging using Swept-source optical coherence tomography (OCT)
Scientific Title:Acronym	Fundus imaging using Swept-source optical coherence tomography (OCT)
Region	Japan

Condition
Condition	Healthy volunteers, or patients with: macular disease (age-related macular degeneration, macular hole, macular pucker etc.), glaucoma, diabetic retinopathy, retinal vein occlusion, adult disease
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To take images of fundus oculi, and evaluate the equipment based on medical perspective. To confirm equipment specific performance for healthy volunteers, and then assess fundus images for various cases, and improve the performance. To develop software applications to extract high-accuracy information.
Basic objectives2	Others
Basic objectives -Others	To examine retinal layered structure.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To take retinal OCT images for healthy volunteers and patients by using the OCT equipment, and assess relationship between image quality, such as contrast, and various cases.
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 examine eligibility and take OCT images in a day.
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Male or female aged 20 to 80 2) Healthy volunteers, or patients with: macular disease (age-related macular degeneration, macular hole, macular pucker etc.), glaucoma, diabetic retinopathy, retinal vein occlusion, adult disease (hypertension, diabetes mellitus) 3) Subjects who sign an informed consent form to participate in the clinical study
Key exclusion criteria	1) Having any side-effects (hypersensitivity, rised intraocular pressure etc.) against mydriatics 2) Revealed narrow angle by slit-lamp examination 3) Subjects who a doctor in attendance declares ineligible for any reason
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Middle name Last name Nagahisa Yoshimura
Organization	Kyoto University Graduate School of Medicine
Division name	Ophthalmology & Visual Sciences
Zip code
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	Kyoto University Graduate School of Medicine
Division name	Ophthalmology & Visual Sciences
Zip code
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL
Homepage URL
Email

Sponsor
Institute	Department of Ophthalmology & Visual Sciences, Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information	2010 Year 06 Month 16 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	Completed
Date of protocol fixation	2010 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date	2010 Year 07 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

Management information
Registered date	2010 Year 06 Month 08 Day
Last modified on	2013 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004509

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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