UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040242 |
|---|---|
| Receipt number | 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 03:21:25 |
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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
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
kimuraitaru@gmail.com
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043189
