UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024540 |
|---|---|
| Receipt number | R000028244 |
| Scientific Title | A multicenter intervention study for assessing the agreement of the Head-Mounted Perimeter 'imo' in its comparability with Humphrey Field Analyzer in detecting visual field defects in patients with brain diseases |
| Date of disclosure of the study information | 2016/10/31 |
| Last modified on | 2022/10/30 23:03:28 |
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Basic information
Public title
A multicenter intervention study for assessing the agreement of the Head-Mounted Perimeter 'imo' in its comparability with Humphrey Field Analyzer in detecting visual field defects in patients with brain diseases
Acronym
Agreement of 'imo' wit Humphrey in detecting visual field defects in patients with brain diseases
Scientific Title
A multicenter intervention study for assessing the agreement of the Head-Mounted Perimeter 'imo' in its comparability with Humphrey Field Analyzer in detecting visual field defects in patients with brain diseases
Scientific Title:Acronym
Agreement of 'imo' wit Humphrey in detecting visual field defects in patients with brain diseases
Region
| Japan |
Condition
Condition
Patients with visual field defects caused by brain diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the comparability between 'imo' and Humphrey in detecting visual field defects in patients with brain diseases.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of agreement of detection of visual field defects between 'imo' binocular random single eye test and Humphrey.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
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 3 to 6 months 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) Patients with visual field defects caused by brain diseases who are between 20 and 70 years old
2) Patients with visual field defects in Humphrey caused by brain disease
3) Male and Female
4) Outpatients
5) Patients with written informed consent by their free will
Key exclusion criteria
1) Patients without binocular vision
2) Patients with intraocular and intracerebral operations within one month of the study
3) Patients who cannot keep fixation of their eyes
4) Patients with visual field defects caused by diseases other than brain disease
5) Patients with difficulties in keeping the posture during the visual field tests
6) Patients who seem to be inappropriate for the study
Target sample size
42
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
650-0017
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
Kitasato University Hospital
The University of Tokyo Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Institutional Review Board of Kobe University
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 31 | Day |
Related information
URL releasing protocol
NA
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s10384-022-00935-y
Number of participants that the trial has enrolled
46
Results
The imo binocular random single eye-test detected VF defects due to chiasmal and post chiasmal lesions as accurately as the HFA monocular test.
Results date posted
| 2022 | Year | 10 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with visual field defects due to
chiasmal and postchiasmal lesions.
Participant flow
The VFs of　patients who completed VF tests with imo and HFA were analyzed.
Adverse events
None.
Outcome measures
The agreement and correlation of VF results between imo and HFA.
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
| 2021 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 24 | Day |
Last modified on
| 2022 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028244
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