UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010482
Receipt number R000012255
Scientific Title Evaluation of optimal stimulus velocity in semi-automated kinetic perimetry
Date of disclosure of the study information 2013/04/12
Last modified on 2015/07/23 09:54:11

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Basic information

Public title

Evaluation of optimal stimulus velocity in semi-automated kinetic perimetry

Acronym

On stimulus velocity in semi-automated kinetic perimetry

Scientific Title

Evaluation of optimal stimulus velocity in semi-automated kinetic perimetry

Scientific Title:Acronym

On stimulus velocity in semi-automated kinetic perimetry

Region

Japan


Condition

Condition

normal younger participant

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To consider the optimal stimulus velocity for semi-automated kinetic perimetry (SKP), based on test duration, kinetic sensitivity, and variability of kinetic sensitivity in healthy younger participants.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

test duration
kinetic sensitivity
variability of kinetic sensitivity

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

perimetric measurement

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

30 years-old >

Gender

Male and Female

Key inclusion criteria

intraocular pressures of 21 mm Hg or less.
no ophthalmic diseases that would influence the visual field test.

Key exclusion criteria

fixation loss recognized on the display.
a lack of fit for corrective contact lenses.

Target sample size

31


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nobuyuki Shoji

Organization

Allied Health Sciences, Kitasato University

Division name

Orthoptics and Visual Science

Zip code


Address

1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0374, Japan

TEL

042-778-8464

Email

nshoji@ahs.kitasato-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazunori Hirasawa

Organization

Graduate school of Medical Science, Kitasato University

Division name

Department of Ophthalmology

Zip code


Address

1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0374, Japan

TEL

042-778-8464

Homepage URL


Email

hirasawa@kitasato-u.ac.jp


Sponsor or person

Institute

Department of Ophthalmology, Graduate school of Medical Science, Kitasato University

Institute

Department

Personal name



Funding Source

Organization

Not funding

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

2013 Year 04 Month 12 Day


Related information

URL releasing protocol


Publication of results

Published


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

2012 Year 05 Month 30 Day

Date of IRB


Anticipated trial start date

2013 Year 06 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



Management information

Registered date

2013 Year 04 Month 12 Day

Last modified on

2015 Year 07 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012255


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name