UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of fixation behavior during monocular and binocular visual field measurement
Title of the study (Brief title)	Investigation of fixation behavior during monocular and binocular visual field measurement
Region	Japan

Condition
Condition	normal subject
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To analyze the fixation behavior during monocular and binocular visual field measurement.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fixation behavior during monocular and binocular visual field measurement.
Key secondary outcomes

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	40 years-old >
Gender	Male and Female
Key inclusion criteria	Normal optic disc temperance. IOP is less than 21mmHg. Spherical refraction is within -8 to +3 diopter. Astigmatic refraction is less than -1.50 diopter.
Key exclusion criteria	The participants who had unreliability criteria with Humphrey Field Analyzer (fixation loss more than 20% and false positive more than 15%)
Target sample size	30

Research contact person
Name of lead principal investigator	Kazunori HIRASAWA
Organization	School of Allied Health Science, KITASATO University
Division name	Department of Orthoptic and Visual Science
Address	1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, JAPAN
TEL	0427789671
Email	hirasawa@kitasato-u.ac.jp

Public contact
Name of contact person	Kazunori Hirasawa
Organization	School of Allied Health Sciences, Kitasato University
Division name	Department of Orthoptic and Visual Science
Address	1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, JAPAN
TEL	0427789671
Homepage URL
Email	hirasawa@kitasato-u.ac.jp

Sponsor
Institute	School of Allied Health Sciences, KITASATO University.
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 05 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 05 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	prospective study

Management information
Registered date	2016 Year 05 Month 20 Day
Last modified on	2016 Year 11 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025796