UMIN-CTR Clinical Trial

Basic information
Public title	Development of a visual field measurement application
Acronym	Development of a visual field measurement application
Scientific Title	Development of a visual field measurement application
Scientific Title:Acronym	Development of a visual field measurement application
Region	Japan

Condition
Condition	Diseases that cause visual field defects
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the feasibility of recording visual field measurements using an iPhone-mounted visual field measurement research application.
Basic objectives2	Others
Basic objectives -Others	not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection of marriott blind spot (Examining the accuracy of the marriott blind spot measurement)
Key secondary outcomes	Age, gender, Ophthalmologic history, etc. (Profiling by comparing measurement results by age, gender, ophthalmologic history, etc.)

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	Prevention
Type of intervention	Other
Interventions/Control_1	Visual field measurement
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	Japanese people over 20 years old who have downloaded research apps published on "TestFlight" or "Research Kit", Apple's framework for medical research
Key exclusion criteria	No exclusion criteria
Target sample size	5600

Research contact person
Name of lead principal investigator	1st name Masahiro Middle name Last name Miyake
Organization	Kyoto University Graduate School of Medicine
Division name	Ophthalmology & Visual Sciences
Zip code	606-8507
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL	075-751-3250
Email	miyakem@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Masahiro Middle name Last name Miyake
Organization	Kyoto University Graduate School of Medicine
Division name	Ophthalmology & Visual Sciences
Zip code	606-8507
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL	075-751-3250
Homepage URL
Email	miyakem@kuhp.kyoto-u.ac.jp

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

Funding Source
Organization	FINDEX Inc.
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	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-u.ac.jp

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	2022 Year 09 Month 01 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
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	Preinitiation
Date of protocol fixation	2022 Year 07 Month 22 Day
Date of IRB
Anticipated trial start date	2022 Year 09 Month 01 Day
Last follow-up date	2026 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 08 Month 15 Day
Last modified on	2022 Year 08 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055446