UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The development of a new method for evaluation of glaucoma (The relationship between ocular circulation and neural activity in glaucoma patients)
Title of the study (Brief title)	The relationship between ocular circulation and neural activity in glaucoma patients
Region	Japan

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

Objectives
Narrative objectives1	To assess the relationship between the ocular circulation and neural activity in glaucoma patients
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood flow alteration in response to flicker stimuli
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Flickering Stimuli
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	18 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Subjects able to understand the written informed consent and willing to participate evidenced by signing the informed consent Control 1)Normal intraocular pressure, open-angle 2)No glaucomatous changes in the fundus Glaucoma 1)Glaucomatous changes in the fundus 2)Abnormal glaucomatous visual field according to the Anderson-Patella classification in the Swedish interactive threshold algorithm (SITA)-standard strategy of the 30-2 program of the Humphrey field analyzer (HFA)
Key exclusion criteria	1)Cataract and previous cataract surgery 2)High ametropia 3)Subjects with cardiovascular disease such as untreated hypertension and diabetes mellitus 4)Previous ocular surgery 5)Difficulty for perform examination
Target sample size	50

Research contact person
Name of lead principal investigator	Takayuki Kamiya
Organization	Asahikawa Medical University
Division name	Ophthalmology
Address	2-1-1-1 Midorigaoka Higashi Asahikawa, Hokkaido, Japan
TEL	0166-68-2543
Email	t-kamiya@asahikawa-med.ac.jp

Public contact
Name of contact person	Takayuki Kamiya
Organization	Asahikawa Medical University
Division name	Ophthalmology
Address	2-1-1-1 Midorigaoka Higashi Asahikawa, Hokkaido, Japan
TEL	0166-68-2543
Homepage URL
Email	t-kamiya@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa Medical University
Institute
Department

Funding Source
Organization	Asahikawa Medical University
Organization
Division
Category of Funding Organization	Other
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 09 Month 12 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 08 Month 10 Day
Anticipated trial start date	2016 Year 09 Month 20 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

Management information
Registered date	2016 Year 09 Month 06 Day
Last modified on	2017 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027489