UMIN-CTR Clinical Trial

Basic information
Public title	Research on evaluation for verification of technology and performance validity in the development of fixation-free perimeter (including improvement research and performance evaluation, operation training, image and data collection)
Acronym	Research on evaluation for verification of technology and performance validity in the development of fixation-free perimeter (including improvement research and performance evaluation, operation training, image and data collection)
Scientific Title	Research on evaluation for verification of technology and performance validity in the development of fixation-free perimeter (including improvement research and performance evaluation, operation training, image and data collection)
Scientific Title:Acronym	Research on evaluation for verification of technology and performance validity in the development of fixation-free perimeter (including improvement research and performance evaluation, operation training, image and data collection)
Region	Japan

Condition
Condition	visual field defect or suspect
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of visual field measurement results using a fixation-free perimeter and an existing static automated perimeter
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	visual field
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment Other
Interventions/Control_1	Measure visual acuity and refractive power as preparation before examination, and then perform a perimetry test once or multiple times using an existing static automated perimeter and a fixation-free perimeter.
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.Age of 18 years or more 2.Patients who can agree to participate, in his/her own intention
Key exclusion criteria	A person who has reported that he/she previously had abnormal finding related to his/her visual line (especially the visual fixation) when obtaining consent
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Teruo Middle name Last name Aibara
Organization	FINDEX Inc.
Division name	Business Strategy Dept.
Zip code	105-6133
Address	2-4-1,Hamamatsucho,Minato-ku,Tokyo,Japan
TEL	03-5408-3745
Email	qms@findex.co.jp

Public contact
Name of contact person	1st name Atsushi Middle name Last name Matsumoto
Organization	FINDEX Inc.
Division name	Pharmaceutical Affairs Management Office
Zip code	790-0003
Address	4-9-6,Sanbancho,Matsuyama-city,Ehime,Japan
TEL	089-947-3388
Homepage URL
Email	qms@findex.co.jp

Sponsor
Institute	FINDEX Inc.
Institute
Department

Funding Source
Organization	FINDEX Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	EMC Healthcare Co.,Ltd. Ehime University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	FINDEX Inc. Research Ethics Committee
Address	2-4-1,Hamamatsucho,Minato-ku,Tokyo,Japan
Tel	03-5408-3745
Email	qms@findex.co.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	2019 Year 10 Month 07 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	52
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	2019 Year 09 Month 28 Day
Date of IRB	2019 Year 09 Month 28 Day
Anticipated trial start date	2019 Year 10 Month 07 Day
Last follow-up date	2021 Year 09 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 04 Day
Last modified on	2021 Year 11 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043299