UMIN-CTR Clinical Trial

Basic information
Public title	Comparative study of ultra-high resolution OCT and conventional OCT
Acronym	Comparative study of ultra-high resolution OCT and conventional OCT
Scientific Title	Comparative study of ultra-high resolution OCT and conventional OCT
Scientific Title:Acronym	Comparative study of ultra-high resolution OCT and conventional OCT
Region	Japan

Condition
Condition	Normal, retinal disease and glaucoma
Classification by specialty	Ophthalmology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the agreement and precision between the ultra-high resolution OCT and the conventional OCT for full retinal thickness, retinal nerve fiber layer thickness and ganglion cell complex thickness.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Agreement and precision for full retinal thickness, retinal nerve fiber layer thickness and ganglion cell complex thickness.
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	Qualifying examination and retinal tomogram data acquisition 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	Not applicable
Gender	Male and Female
Key inclusion criteria	Normal 1. Subjects who have been diagnosed with normal with normal eye examinations. 2. Subjects able to keep sitting position by themselves for approximately 30 seconds of one measurement and approximately 15 - 20 minutes of whole measurement. 3. Subjects who agree to participate in this study and sign the informed consent form. Retinal disease and glaucoma 1. Subjects who have been diagnosed with retinal disease or glaucoma with normal eye examinations. 2. Subjects able to keep sitting position by themselves for approximately 30 seconds of one measurement and approximately 15 - 20 minutes of whole measurement. 3. Subjects who agree to participate in this study and sign the informed consent form.
Key exclusion criteria	1. Subjects unable to follow fixation. 2. Subjects with cataract unable to measure. 3. Subjects who have medical history for a side effect by using a mydriatic agent.
Target sample size	63

Research contact person
Name of lead principal investigator	1st name Middle name Last name Mineo Kondo
Organization	Mie University Hospital
Division name	Ophthalmology
Zip code
Address	2-174 Edobashi, Tsu, Mie
TEL	059-231-5027
Email	mineo@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Mineo Kondo
Organization	Mie University Hospital
Division name	Ophthalmology
Zip code
Address	2-174 Edobashi, Tsu, Mie
TEL	059-231-5027
Homepage URL
Email	mineo@clin.medic.mie-u.ac.jp

Sponsor
Institute	Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Kowa Company, Ltd.
Organization
Division
Category of Funding Organization	Profit 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	2018 Year 02 Month 27 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	0
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	Terminated
Date of protocol fixation	2018 Year 04 Month 01 Day
Date of IRB	2018 Year 04 Month 01 Day
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date	2020 Year 12 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 02 Month 27 Day
Last modified on	2020 Year 12 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035958