UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016544
Receipt number R000019202
Scientific Title Binocular function in patients with glaucoma
Date of disclosure of the study information 2015/02/16
Last modified on 2015/02/14 22:49:27

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Basic information

Public title

Binocular function in patients with glaucoma

Acronym

Binocular function in patients with glaucoma

Scientific Title

Binocular function in patients with glaucoma

Scientific Title:Acronym

Binocular function in patients with glaucoma

Region

Japan


Condition

Condition

Glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the relationship between Binocular function, Visual field defect and other factors

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Influence of Visual field defect on Binocular function

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

Glaucoma patients and non-glaucoma patients who visited the Ophthalmological Department of Hiroshima university hospital

Key exclusion criteria

Best-corrected VA worse than decimal VA 0.7, strabismus, amblyopia, intraocular surgery (within 3 months), corneal disease and retinal disease

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiaki Kiuchi

Organization

Hiroshima university

Division name

Department of ophthalmology and visual science institute of biomedical & health sciences

Zip code


Address

1-2-3 Kasumi, Minami-ku, Hiroshima

TEL

082-257-5555(5247)

Email

ykiuchi@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshitaka Nakao

Organization

Hiroshima university

Division name

Department of ophthalmology and visual science institute of biomedical & health sciences

Zip code


Address

1-2-3 Kasumi, Minami-ku, Hiroshima

TEL

082-257-5555(5247)

Homepage URL


Email

nakao@hiroshima-u.ac.jp


Sponsor or person

Institute

Department of ophthalmology and visual science institute of biomedical & health sciences

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


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

2015 Year 02 Month 16 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

ongoing

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

2013 Year 09 Month 27 Day

Date of IRB


Anticipated trial start date

2013 Year 10 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

prospective study


Management information

Registered date

2015 Year 02 Month 14 Day

Last modified on

2015 Year 02 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019202


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name