UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024539 |
|---|---|
| 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 |
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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
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
mariwsakamoto@people.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Division of Ophthalmology Department of Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028243
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