UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040242
Receipt number R000043189
Scientific Title The investigation of correlation between head-mounted perimeter "imo" and Humphrey Field Analyzer(10-2)
Date of disclosure of the study information 2020/04/27
Last modified on 2020/04/27 03:21:25

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Basic information

Public title

The investigation of correlation between head-mounted perimeter "imo" and Humphrey Field Analyzer(10-2)

Acronym

The investigation of correlation between "imo" and HFA

Scientific Title

The investigation of correlation between head-mounted perimeter "imo" and Humphrey Field Analyzer(10-2)

Scientific Title:Acronym

The investigation of correlation between "imo" and HFA

Region

Japan


Condition

Condition

Glaucoma,optic nerve diseases, and vitreoretinal diseases

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Head-mounted perimeters "imo" have been developed recently, and the need for a portable perimeter that can be used for examination anytime and anywhere, without the need for patients to maintain a fixed position was satisfied. this perimeter can examine bilateral visual field simultaneously, in much shorter measurement time. imo is expected to become popular rapidly. This perimeter, however, has not have no investigation as to the correlation of the measurement results between imo and Humpherey field analyzer(10-2) yet. The purpose of this study is to investigate the correlation between imo and Humpherey field analyzer(10-2) in eye disease patients (glaucoma and so on) with visual field defect, and patients without visual field defect.

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The correlation coefficient between measurement results of imo and Humpherey Field Analyzer(10-2)

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

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Visual field test
imo(AIZE 10-2) & Humphrey(SITA-standard 10-2)
one time each during 3 months

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with normal visual field

age 20y/o or more, under 80y/o
spherical equivalent -10.0D or more, under 2.0D
corrected visual acuity 0.8 or more
intra ocular pressure under 20mmHg
within normal limit by Humphrey visual field analyzer

Patients with visual field disturbance

age 20y/o or more, under 80y/o
spherical equivalent -10.0D or more, under 2.0D
corrected visual acuity 0.8 or more
MD values -25 dB or more, under-5 dB (at least one eye satisfies this criterion)

Key exclusion criteria

Patients with normal visual field

patients with disease which cause visual field disturbance
color vision deficiency
patients who underwent ophthalmic surgeries
patients with abnormal findings at ocular fundus
patients who can not posture for visual field tests

Patients with visual field disturbance

patients who underwent intraocular surgeries within 1 month
patients who can not posture for visual field tests

Target sample size

90


Research contact person

Name of lead principal investigator

1st name Itaru
Middle name
Last name Kimura

Organization

Tokai University Hachioji Hospital

Division name

Department of Ophthalmology

Zip code

192-0032

Address

1838 Ishikawa-machi Hachioji City Tokyo Japan

TEL

042-639-1111

Email

kimuraitaru@gmail.com


Public contact

Name of contact person

1st name Itaru
Middle name
Last name Kimura

Organization

Tokai University Hachioji Hospital

Division name

Department of Ophthalmology

Zip code

192-0032

Address

1838 Ishikawa-machi Hachioji City Tokyo Japan

TEL

042-639-1111

Homepage URL


Email

kimuraitaru@gmail.com


Sponsor or person

Institute

Tokai University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional review board for clinical research, Tokai University

Address

143 Shimo-Kasuya Isehara City, Kanagawa Japan

Tel

0463-93-1121

Email

tokai-rinsho@ml.tokai-u.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

東海大学医学部付属八王子病院(東京都)、埼玉医科大学病院(埼玉県)、吉川眼科クリニック(東京都)、上野眼科クリニック(東京都)、すずむら眼科医院(東京都)、神楽坂みなみの眼科(東京都)


Other administrative information

Date of disclosure of the study information

2020 Year 04 Month 27 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2019 Year 04 Month 11 Day

Date of IRB

2019 Year 08 Month 26 Day

Anticipated trial start date

2019 Year 08 Month 26 Day

Last follow-up date

2021 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 04 Month 27 Day

Last modified on

2020 Year 04 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043189


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name