UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013871
Receipt number R000016178
Scientific Title Study of the tear secretion's function with new strip meniscometry tube part 1: Influence of visual field test to tear film and ocular surface
Date of disclosure of the study information 2014/05/10
Last modified on 2019/05/31 16:21:51

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Basic information

Public title

Study of the tear secretion's function with new strip meniscometry tube part 1: Influence of visual field test to tear film and ocular surface

Acronym

Influence of visual field test to tear film and ocular surface

Scientific Title

Study of the tear secretion's function with new strip meniscometry tube part 1: Influence of visual field test to tear film and ocular surface

Scientific Title:Acronym

Influence of visual field test to tear film and ocular surface

Region

Japan


Condition

Condition

glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the influence of visual field test to tear film and ocular surface

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Examination of tear with strip meniscometry tube

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

10 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

Glaucoma patients who need visual field test

Key exclusion criteria

The patients who do not wish the test

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Tetuju
Middle name
Last name Sekiryu

Organization

Fukushima medical university school of medicine

Division name

department of ophthalmology

Zip code

960-1295

Address

1 Hikariga-oka, Fukushima City, Fukushima Prefecture 960-1295, Japan.

TEL

024-547-1111

Email

sekiryu@fmu.ac.jp


Public contact

Name of contact person

1st name Hideto
Middle name
Last name Sagara

Organization

Marui Eye Clinic

Division name

Director

Zip code

975-0062

Address

1-83-3, Honjinmae Haramachi-ku, Minamisouma City, Fukushima Prefecture 975-0062, Japan

TEL

0244-24-0101

Homepage URL


Email

hide1234@ruby.ocn.ne.jp


Sponsor or person

Institute

Department of ophthalmology, Fukushima medical university school of medicine

Institute

Department

Personal name



Funding Source

Organization

Marui Eye Clinic

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Marui Eye Clinic

Address

1-83-3, Honjinmae Haramachi, Minamisoma, Fukushima 975-0062, Japan

Tel

+81 244 24 0101

Email

hide1234@ruby.ocn.ne.jp


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

2014 Year 05 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

Completed

Date of protocol fixation

2014 Year 05 Month 02 Day

Date of IRB

2014 Year 04 Month 01 Day

Anticipated trial start date

2014 Year 05 Month 07 Day

Last follow-up date

2018 Year 01 Month 28 Day

Date of closure to data entry

2019 Year 05 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

We check the amount of tear with strip meniscometry tube before and after visual fild test.


Management information

Registered date

2014 Year 05 Month 02 Day

Last modified on

2019 Year 05 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016178


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name