Unique ID issued by UMIN | UMIN000024539 |
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Receipt number | R000028243 |
Scientific Title | An intervention study for assessing the agreement of the Head-Mounted Perimeter 'imo' with Humphrey Field Analyzer in detecting glaucomatous visual field defects |
Date of disclosure of the study information | 2016/10/31 |
Last modified on | 2022/04/29 21:05:44 |
An intervention study for assessing the agreement of the Head-Mounted Perimeter 'imo' with Humphrey Field Analyzer in detecting glaucomatous visual field defects
Agreement of 'imo' with Humphrey in detecting glaucomatous visual field defects
An intervention study for assessing the agreement of the Head-Mounted Perimeter 'imo' with Humphrey Field Analyzer in detecting glaucomatous visual field defects
Agreement of 'imo' with Humphrey in detecting glaucomatous visual field defects
Japan |
glaucoma
Ophthalmology |
Others
NO
To assess the agreement in detecting glaucomatous visual field defects between 'imo' and Humphrey
Bio-equivalence
Exploratory
Pragmatic
Not applicable
95% agreement of MD values of 'imo' binocular random single eye test and Humphrey
1 Visual field defect patterns of 'imo' binocular random single eye test and Humphrey
2 Test time for the two perimeters
3 Fixation of eyes during the test for the two perimeters
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
No need to know
1
Prevention
Device,equipment |
Test visual field with 1)imo binocular random single eye test and 2)Humphrey in order on the test day1 and then re-test visual field with the two perimeters in the same order on the test day2 8 weeks after day1.
20 | years-old | <= |
70 | years-old | >= |
Male and Female
1) Glaucoma patients between 20 and 70 years old who regularly visit Kobe university hospital at least once in every two months.
2) all types of glaucoma
3) MD value of Humphrey between -6dB and -15dB
4) Male and Female
5) Outpatients
6) Patients with written informed consent by their free will
1) Patients without binocular vision
2) Patients with intraocular operations within one month of the study
3) Patients who cannot keep fixation of their eyes
4) Patients with difficulties in keeping the posture during the visual field tests
5) Patients who seem to be inappropriate for the study
60
1st name | Makoto |
Middle name | |
Last name | Nakamura |
Kobe University Graduate School of Medicine
Division of Ophthalmology Department of Surgery
6500017
7-5-2 Kusunoki-cho, Chuou-ku, Kobe city, Hyogo 650-0017 Japan
078-382-6048
manakamu@med.kobe-u.ac.jp
1st name | Mari |
Middle name | |
Last name | Sakamoto |
Kobe University Graduate School of Medicine
Division of Ophthalmology Department of Surgery
6500017
7-5-2 Kusunoki-cho, Chuou-ku, Kobe city, Hyogo 650-0017 Japan
078-382-6048
mariwsakamoto@people.kobe-u.ac.jp
Kobe University Graduate School of Medicine
Division of Ophthalmology Department of Surgery
None
Other
Institutional Review Board of Kobe University Hospital
7-5-2 Kusunoki-cho, Chuou-ku, Kobe city, Hyogo 650-0017 Japan
078-382-6669
kainyu@med.kobe-u.ac.jp
NO
神戸大学附属病院(兵庫県)
2016 | Year | 10 | Month | 31 | Day |
http://journal.nichigan.or.jp/Disp?style=abst&vol=125&mag=0&number=5&start=530
Published
http://journal.nichigan.or.jp/Disp?style=abst&vol=125&mag=0&number=5&start=530
67
Seven out of the 67 subjects could not perform the imo BRSET. The BRSET test time was 25% shorter than that of HFA. The imo MS and FT were significantly smaller than the HFA counterparts bilaterally, and the HFA MD was smaller than the imo MD in the left eyes. The MS, MD, PSD, and VFI all showed a high correlation between the two tests. The survey revealed that 89% of the patients preferred imo over HFA.
2022 | Year | 04 | Month | 29 | Day |
Among the glaucoma outpatients of the Kobe University Hospital, we included those aged between 20 and 70 years and whose mean deviation (MD) of the eye with the greatest progression of visual field impairment on the Humphrey Filed Analyzer (HFA) 30-2 test was between -15 dB and -6 dB.
The imo 30-2 binocular random single-eye test (BRSET) and the HFA 30-2
were measured on the same day, and the tests were repeated two months later.
None.
The number of the subjects who could perform BRSET was counted, and the testing time, mean sensitivity (MS), MD, pattern
standard deviation (PSD), visual field index (VFI), and foveal threshold (FT) were compared. A questionnaire survey was conducted after the tests.
Completed
2016 | Year | 10 | Month | 17 | Day |
2017 | Year | 02 | Month | 23 | Day |
2017 | Year | 03 | Month | 01 | Day |
2020 | Year | 06 | Month | 01 | Day |
2020 | Year | 06 | Month | 01 | Day |
2020 | Year | 06 | Month | 01 | Day |
2020 | Year | 09 | Month | 01 | Day |
2016 | Year | 10 | Month | 24 | Day |
2022 | Year | 04 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028243
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