UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007775
Receipt number R000009137
Scientific Title Elucidation of the mechanism of light sneeze reflex and its relevance with retinal diseases
Date of disclosure of the study information 2012/04/18
Last modified on 2013/07/30 15:25:39

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Basic information

Public title

Elucidation of the mechanism of light sneeze reflex and its relevance with retinal diseases

Acronym

Elucidation of the mechanism of light sneeze reflex and its relevance with retinal diseases

Scientific Title

Elucidation of the mechanism of light sneeze reflex and its relevance with retinal diseases

Scientific Title:Acronym

Elucidation of the mechanism of light sneeze reflex and its relevance with retinal diseases

Region

Japan


Condition

Condition

healthy volunteers

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To elucidate the mechanism of light sneeze reflex by examining ophthalmological characteristics.
To elucidate the relationship between light sneeze reflex and retinal diseases such as age related macular degeneration.

Basic objectives2

Others

Basic objectives -Others

observational study, epidemiologic study

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Macular pigment optical density

Key secondary outcomes

Medical examination by interview
Best corrected visual acuity
Contrast sensitivity
Contrast sensitivity under glare


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

50 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with retinal diseases such as age related macular degeneration and healthy volunteers without eye diseases

Key exclusion criteria

eyes with low reliability of examinations

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kohji Nisihda

Organization

Osaka University Graduate School of Medicine

Division name

Ophthalomogy

Zip code


Address

2-2 Yamadaoka, Suita, Osaka, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Osaka University Graduate School of Medicine

Division name

Ophthalomogy

Zip code


Address

2-2 Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-5111

Homepage URL


Email



Sponsor or person

Institute

Kohji Nishida

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

2012 Year 04 Month 18 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

Terminated

Date of protocol fixation

2012 Year 04 Month 14 Day

Date of IRB


Anticipated trial start date

2012 Year 04 Month 01 Day

Last follow-up date

2013 Year 07 Month 30 Day

Date of closure to data entry

2013 Year 07 Month 30 Day

Date trial data considered complete

2013 Year 07 Month 30 Day

Date analysis concluded

2013 Year 07 Month 30 Day


Other

Other related information

factors: eye diseases, medical examination by interview, age, gender, best corrected visual acuity, contrast sensitivity, contrast sensitivity under glare, macular pigment optical density

cross sectional study


Management information

Registered date

2012 Year 04 Month 16 Day

Last modified on

2013 Year 07 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009137


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name