UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034654
Receipt number R000039509
Scientific Title Effect of massage around eyes on ocular blood flow and vision.
Date of disclosure of the study information 2018/10/26
Last modified on 2019/10/27 10:30:52

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Basic information

Public title

Effect of massage around eyes on ocular blood flow and vision.

Acronym

Effect of massage around eyes on ocular blood flow and vision.

Scientific Title

Effect of massage around eyes on ocular blood flow and vision.

Scientific Title:Acronym

Effect of massage around eyes on ocular blood flow and vision.

Region

Japan


Condition

Condition

none (healthy subjects)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate effects of four types of massage around eye on ocular blood flow and vision in healthy subjects.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Ocular blood flow obtained by laser speckle flowgraphy, and static vision, dynamic vision and contrast sensitivity, one and two months after the start of daily massage

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Daily five-min Chinese eye exercise for two months. Massage is applied on one eye.

Interventions/Control_2

Daily five-min massage by massage roller for two months. Massage is applied on one eye.

Interventions/Control_3

Daily five-min massage by mechanical eye massage apparatus for two months. Massage is applied on both eyes.

Interventions/Control_4

No massage

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

39 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy. No medical treatment nor medication.

Key exclusion criteria

Diseases and hypertension. Medical treatment and medication. Hay fever is excluded during its season (mainly spring).

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Naoyuki
Middle name
Last name Hayashi

Organization

Tokyo Institute of Technology

Division name

Institute for Liberal Arts

Zip code

1528552

Address

2-12-1-W9-1, Ookayama, Meguro, Tokyo , Japan

TEL

03-5734-3434

Email

naohayashi@ila.titech.ac.jp


Public contact

Name of contact person

1st name anonymous
Middle name
Last name anonymous

Organization

Tokyo Institute of Technology

Division name

Research Planning Division

Zip code

1528552

Address

2-12-1, Ookayama, Meguro, Tokyo , Japan

TEL

03-5734-3802

Homepage URL


Email

kenkik.som@jim.titech.ac.jp


Sponsor or person

Institute

Tokyo Institute of Technology

Institute

Department

Personal name



Funding Source

Organization

Tokyo Institute of Technology

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

Tokyo Institute of Technology

Address

Ookayama 2-12-1-E3-10, Meguro, Tokyo 1528550, Japan

Tel

03-5734-3808

Email

hitorinri@jim.titech.ac.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

2018 Year 10 Month 26 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

40

Results

Daily five-min massage around the eyes for two months did not significantly affect visual functions and ocular blood flow.

Results date posted

2019 Year 08 Month 27 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events

none

Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 07 Month 01 Day

Date of IRB

2018 Year 08 Month 07 Day

Anticipated trial start date

2019 Year 01 Month 20 Day

Last follow-up date

2019 Year 05 Month 20 Day

Date of closure to data entry

2019 Year 07 Month 10 Day

Date trial data considered complete

2019 Year 07 Month 21 Day

Date analysis concluded

2019 Year 08 Month 26 Day


Other

Other related information



Management information

Registered date

2018 Year 10 Month 26 Day

Last modified on

2019 Year 10 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039509


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name