UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022685
Receipt number R000026144
Scientific Title Binocular vision and QOL for glaucomatous visual field defect
Date of disclosure of the study information 2016/06/10
Last modified on 2021/01/03 15:00:17

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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 or person

Institute

Kanazawa University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026144


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name