UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of fixation behavior during the perimetry test
Title of the study (Brief title)	Fixation behavior during the perimetry test
Region	Japan

Condition
Condition	healthy participants
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluated the fixation behavior during the perimetery test.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	fixation behavior
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	40 years-old >
Gender	Male and Female
Key inclusion criteria	astigmatic power is less than 1.50D, intraocular pressure is less than 21mmHg, visual acuity more than 1.0.
Key exclusion criteria	astigmatic power is more than 1.50D, intraocular pressure is more than 22mmHg, visual acuity is less than 0.9.
Target sample size	30

Research contact person
Name of lead principal investigator	Nobuyuki Shoji
Organization	School of Allied Health Sciences, Kitasato University
Division name	Orthoptics and Visual Science
Address	1-15-1, Kitasato, Minami-ku,Sagamihara ,Kanagawa, Japan
TEL	0.42-778-9671
Email	nshoji@ahs.kitasato-u.ac.jp

Public contact
Name of contact person	Kazunori Hirasawa
Organization	School of Allied health sciences, KITASATO University
Division name	Orthoptics and Visual Science
Address	1-15-1, Kitasato, Minami-ku,Sagamihara ,Kanagawa, Japan
TEL	042-778-9671
Homepage URL
Email	hirasawa@kitasato-u.ac.jp

Sponsor
Institute	School of Allied Health Sciences, Kitasato University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	School of Allied Health Sciences, Kitasato University
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	2015 Year 07 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 08 Day
Anticipated trial start date	2015 Year 06 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2015 Year 12 Month 05 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	case control study

Management information
Registered date	2015 Year 07 Month 23 Day
Last modified on	2016 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021299