UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031761
Receipt number R000036261
Scientific Title Evaluation of visual response on Light Field Display
Date of disclosure of the study information 2020/07/31
Last modified on 2021/03/02 10:10:09

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Basic information

Public title

Evaluation of visual response on Light Field Display

Acronym

Evaluation of Light Field Display

Scientific Title

Evaluation of visual response on Light Field Display

Scientific Title:Acronym

Evaluation of Light Field Display

Region

Japan


Condition

Condition

Normal individuals

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate vergence-accommodation conflict using light field display.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Accommodative- and vergence-response

Key secondary outcomes

Age; Angle of deviation


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

Interventions/Control_1

Accommodative stimulus between 1.0 m and 0.33 (or 0.50) m.

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

45 years-old >

Gender

Male and Female

Key inclusion criteria

Those who do not have ophthalmological diseases other than refractive error.

Key exclusion criteria

Those over 45 years old.

Target sample size

15


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

Toppan Printing Co., Ltd.

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

2020 Year 07 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

2018 Year 03 Month 14 Day

Date of IRB

2018 Year 03 Month 29 Day

Anticipated trial start date

2018 Year 04 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 03 Month 16 Day

Last modified on

2021 Year 03 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036261


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name