UMIN-CTR Clinical Trial

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
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	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
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

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028244