UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023193
Receipt number R000026737
Scientific Title Objective determination of asthenopia.
Date of disclosure of the study information 2017/01/31
Last modified on 2017/02/14 12:03:30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Objective determination of asthenopia.

Acronym

Objective determination of asthenopia.

Scientific Title

Objective determination of asthenopia.

Scientific Title:Acronym

Objective determination of asthenopia.

Region

Japan


Condition

Condition

Asthenopia

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the objective evaluation of asthenopia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The latency of convergence, the velocity of accommodation, binocular visual function.

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

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

TV-game for 30 minutes.

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

35 years-old <=

Age-upper limit

45 years-old >=

Gender

Male and Female

Key inclusion criteria

No eye disease without refractive error.

Key exclusion criteria

Volunteers who have eye disease without refractive error.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Fujikado

Organization

Osaka university graduate school of medicine

Division name

Department of applied visual science

Zip code


Address

2-2 Yamadaoka, Suita, Osaka

TEL

0668793941

Email

fujikado@ophthal.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masakazu Hirota

Organization

Osaka university graduate school of medicine

Division name

Department of applied visual science

Zip code


Address

2-2 Yamadaoka, Suita, Osaka

TEL

0668793941

Homepage URL


Email

hirota.sensory@gmail.com


Sponsor or person

Institute

Osaka university

Institute

Department

Personal name



Funding Source

Organization

Research expenses for joint experimental research

Organization

Division

Category of Funding Organization

Profit organization

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

2017 Year 01 Month 31 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

2016 Year 07 Month 31 Day

Date of IRB


Anticipated trial start date

2016 Year 07 Month 31 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

2016 Year 07 Month 15 Day

Last modified on

2017 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=R000026737


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name