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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000024539
Receipt No. 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

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Basic information
Public title An intervention study for assessing the agreement of the Head-Mounted Perimeter 'imo' with Humphrey Field Analyzer in detecting glaucomatous visual field defects
Acronym Agreement of 'imo' with Humphrey in detecting glaucomatous visual field defects
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
Scientific Title:Acronym Agreement of 'imo' with Humphrey in detecting glaucomatous visual field defects
Region
Japan

Condition
Condition glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the agreement in detecting glaucomatous visual field defects between 'imo' and Humphrey
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 95% agreement of MD values of 'imo' binocular random single eye test and Humphrey
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 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.
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Makoto
Middle name
Last name Nakamura
Organization Kobe University Graduate School of Medicine
Division name Division of Ophthalmology Department of Surgery
Zip code 6500017
Address 7-5-2 Kusunoki-cho, Chuou-ku, Kobe city, Hyogo 650-0017 Japan
TEL 078-382-6048
Email manakamu@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Mari
Middle name
Last name Sakamoto
Organization Kobe University Graduate School of Medicine
Division name Division of Ophthalmology Department of Surgery
Zip code 6500017
Address 7-5-2 Kusunoki-cho, Chuou-ku, Kobe city, Hyogo 650-0017 Japan
TEL 078-382-6048
Homepage URL
Email mariwsakamoto@people.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Division of Ophthalmology Department of Surgery
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Institutional Review Board of Kobe University Hospital
Address 7-5-2 Kusunoki-cho, Chuou-ku, Kobe city, Hyogo 650-0017 Japan
Tel 078-382-6669
Email kainyu@med.kobe-u.ac.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 神戸大学附属病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 31 Day

Related information
URL releasing protocol http://journal.nichigan.or.jp/Disp?style=abst&vol=125&mag=0&number=5&start=530
Publication of results Published

Result
URL related to results and publications http://journal.nichigan.or.jp/Disp?style=abst&vol=125&mag=0&number=5&start=530
Number of participants that the trial has enrolled 67
Results 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.
Results date posted
2022 Year 04 Month 29 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 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.
Participant flow 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.
Adverse events None.
Outcome measures 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.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 10 Month 17 Day
Date of IRB
2017 Year 02 Month 23 Day
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
2020 Year 06 Month 01 Day
Date of closure to data entry
2020 Year 06 Month 01 Day
Date trial data considered complete
2020 Year 06 Month 01 Day
Date analysis concluded
2020 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 24 Day
Last modified on
2022 Year 04 Month 29 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028243

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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