UMIN-CTR Clinical Trial

Basic information
Public title	Binocular vision and QOL for glaucomatous visual field defect
Acronym	Binocular vision and QOL for glaucoma
Scientific Title	Binocular vision and QOL for glaucomatous visual field defect
Scientific Title:Acronym	Binocular vision and QOL for glaucoma
Region	Japan

Condition
Condition	primary open angle glaucoma,Normal people
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Analyze the relationship glaucomatous visual field defect,binocular vision and Quality of Life
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship glaucomatous visual field defect and Binocular Vision and Quality of Life
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Written informed consent: Patients capable of providing written consent by themselves after full explanation of the study details using written information to patients. (2) Patients aged 20 years or older who are capable of providing consent. (3) Males and females. (4)Primary open angle glaucoma (5)Normal people
Key exclusion criteria	1) History of disease which affect the visual field sensitivity except glaucoma. 2) Patients with history of refractive surgery, vitreous surgery or retinal detachment surgery. 3)Strabismus 4)History of amblyopia (annisometropic amblyopia and refractive amblyopia) 5) Unable to perform visual field test. 6) Patients whom doctor judged to be ineligible for this study.
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuhisa Sugiyama
Organization	Kanazawa University Graduate School of Medical Science
Division name	Department of Ophthalmology
Zip code
Address	13-1 Takara-machi, Kanazawa, Ishikawa
TEL	076-265-2000
Email	ganjimu2@med.kanazawa-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Sachiko Udagawa
Organization	Kanazawa University Graduate School of Medical Science
Division name	Department of Ophthalmology
Zip code
Address	13-1 Takara-machi, Kanazawa, Ishikawa
TEL	076-265-2000
Homepage URL
Email	s-uda@med.kanazawa-u.ac.jp

Sponsor
Institute	Kanazawa University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tajimi Iwase eye clinic: Aiko Iwase Ohkubo eye clinic: Shinji Ohkubo
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 06 Month 10 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	Open public recruiting
Date of protocol fixation	2015 Year 09 Month 01 Day
Date of IRB	2014 Year 11 Month 19 Day
Anticipated trial start date	2016 Year 06 Month 10 Day
Last follow-up date	2024 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Visual field defect Binocular vision Quality of Life

Management information
Registered date	2016 Year 06 Month 09 Day
Last modified on	2021 Year 01 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026144