UMIN-CTR Clinical Trial

Basic information
Public title	The investigation of correlation between head-mounted perimeter "imo" and Humphrey Field Analyzer(10-2)
Acronym	The investigation of correlation between "imo" and HFA
Scientific Title	The investigation of correlation between head-mounted perimeter "imo" and Humphrey Field Analyzer(10-2)
Scientific Title:Acronym	The investigation of correlation between "imo" and HFA
Region	Japan

Condition
Condition	Glaucoma,optic nerve diseases, and vitreoretinal diseases
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Head-mounted perimeters "imo" have been developed recently, and the need for a portable perimeter that can be used for examination anytime and anywhere, without the need for patients to maintain a fixed position was satisfied. this perimeter can examine bilateral visual field simultaneously, in much shorter measurement time. imo is expected to become popular rapidly. This perimeter, however, has not have no investigation as to the correlation of the measurement results between imo and Humpherey field analyzer(10-2) yet. The purpose of this study is to investigate the correlation between imo and Humpherey field analyzer(10-2) in eye disease patients (glaucoma and so on) with visual field defect, and patients without visual field defect.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The correlation coefficient between measurement results of imo and Humpherey Field Analyzer(10-2)
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
Interventions/Control_1	Visual field test imo(AIZE 10-2) & Humphrey(SITA-standard 10-2) one time each during 3 months
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	Patients with normal visual field age 20y/o or more, under 80y/o spherical equivalent -10.0D or more, under 2.0D corrected visual acuity 0.8 or more intra ocular pressure under 20mmHg within normal limit by Humphrey visual field analyzer Patients with visual field disturbance age 20y/o or more, under 80y/o spherical equivalent -10.0D or more, under 2.0D corrected visual acuity 0.8 or more MD values -25 dB or more, under-5 dB (at least one eye satisfies this criterion)
Key exclusion criteria	Patients with normal visual field patients with disease which cause visual field disturbance color vision deficiency patients who underwent ophthalmic surgeries patients with abnormal findings at ocular fundus patients who can not posture for visual field tests Patients with visual field disturbance patients who underwent intraocular surgeries within 1 month patients who can not posture for visual field tests
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Itaru Middle name Last name Kimura
Organization	Tokai University Hachioji Hospital
Division name	Department of Ophthalmology
Zip code	192-0032
Address	1838 Ishikawa-machi Hachioji City Tokyo Japan
TEL	042-639-1111
Email	kimuraitaru@gmail.com

Public contact
Name of contact person	1st name Itaru Middle name Last name Kimura
Organization	Tokai University Hachioji Hospital
Division name	Department of Ophthalmology
Zip code	192-0032
Address	1838 Ishikawa-machi Hachioji City Tokyo Japan
TEL	042-639-1111
Homepage URL
Email	kimuraitaru@gmail.com

Sponsor
Institute	Tokai University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Institutional review board for clinical research, Tokai University
Address	143 Shimo-Kasuya Isehara City, Kanagawa Japan
Tel	0463-93-1121
Email	tokai-rinsho@ml.tokai-u.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	東海大学医学部付属八王子病院(東京都)、埼玉医科大学病院(埼玉県)、吉川眼科クリニック(東京都)、上野眼科クリニック(東京都)、すずむら眼科医院(東京都)、神楽坂みなみの眼科(東京都)

Other administrative information
Date of disclosure of the study information	2020 Year 04 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
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	Enrolling by invitation
Date of protocol fixation	2019 Year 04 Month 11 Day
Date of IRB	2019 Year 08 Month 26 Day
Anticipated trial start date	2019 Year 08 Month 26 Day
Last follow-up date	2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 04 Month 27 Day
Last modified on	2020 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043189