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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040242
Receipt No. R000043189
Scientific Title The investigation of correlation between head-mounted perimeter "imo" and Humphrey Field Analyzer(10-2)
Date of disclosure of the study information 2020/04/27
Last modified on 2020/04/27

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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

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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