UMIN-CTR Clinical Trial

Basic information
Public title	A comparison of Head-Mounted Perimeter 'imo' with Humphrey Field Analyzer
Acronym	A comparison of 'imo' with Humphrey
Scientific Title	A comparison of Head-Mounted Perimeter 'imo' with Humphrey Field Analyzer
Scientific Title:Acronym	A comparison of 'imo' with Humphrey
Region	Japan

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

Objectives
Narrative objectives1	To assess the results of the detecting glaucomatous visual field defects between 'imo' and Humphrey
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Agreement with MD values of 'imo' and Humphrey perimeter
Key secondary outcomes	Test time for the two perimeters Fixation of eyes during the test for the two perimeters

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with glaucomatous visual field damage Test visual field with Humphrey Patients who are willing to participate in the study, and who are able to provide written informed consent Patients able to visit the medical institution at pre-defined visits
Key exclusion criteria	MD value of Humphrey < -30dB Patients who show best corrected decimal visual acuity less than 0.1
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Tomoko Middle name Last name Naito
Organization	Okayama Univ. Hospital
Division name	Ophthalmology
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku,Okayama-shi,Okayama
TEL	086-235-7297
Email	tomokoum@gmail.com

Public contact
Name of contact person	1st name Takako Middle name Last name Miki
Organization	Okayama Univ. Hospital
Division name	Ophthalmology
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku,Okayama-shi,Okayama
TEL	086-235-7297
Homepage URL
Email	higo_oka@yahoo.co.jp

Sponsor
Institute	Okayama Univ. Hospital
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	Okayama University
Address	700-8558 2-5-1 Shikata-cho Kita-ku Okayama city
Tel	086-235-6503
Email	mae6605@adm.okayama-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	2018 Year 07 Month 04 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	2018 Year 06 Month 22 Day
Date of IRB	2018 Year 06 Month 22 Day
Anticipated trial start date	2018 Year 06 Month 22 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Study duration:from 2018/6 to 2021/6 Subjects:All subjects that our hospital visited by glaucoma, and met the selection criteria.

Management information
Registered date	2018 Year 07 Month 04 Day
Last modified on	2019 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037916