UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018664
Receipt number R000021561
Scientific Title Efficacy of pinhole contact lens with no refractive power
Date of disclosure of the study information 2015/08/17
Last modified on 2016/10/25 17:50:24

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Basic information

Public title

Efficacy of pinhole contact lens with no refractive power

Acronym

Efficacy of pinhole contact lens with no refractive power

Scientific Title

Efficacy of pinhole contact lens with no refractive power

Scientific Title:Acronym

Efficacy of pinhole contact lens with no refractive power

Region

Japan


Condition

Condition

myopia, myopic astigmatism and presbyopia

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of refractive and presbyopic correction with the pin-hole conatact lens.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase



Assessment

Primary outcomes

Distance and near visual acuities with or without the pinhole contact lens.

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

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Use of a pinhole contact lens

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

50 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) 50 years old and over
2) myopia and myopic astigmatism with corrected visual acuity of 1.0 and over
3) The astigmatism (the column frequency) is less than 1/2 of the spherical surface frequency
4) The person that the observation of both eyes is possible
5) The person possible to come for examination on the specified day
6) The person who I understand instructions and the explanation of the doctor, and can acquire an agreement

Key exclusion criteria

1) Subjects who cannot wear a contact lens
2) Corneal endothelial cell density < 2000/ mm2
3)Corneal diameter < 10 mm
4) Subjects who have ocular diseases affecting visual function except for refractive error and presbyopia
5) A pregnant woman, a woman nursing or woman with the plan of the pregnancy
6) The patient (AIDS, autoimmune disease) with the immune disease or diabetic
7) The person who cannot obey the instructions of the ophthalmology specialist
8) Extremely nervous person
9) Person not able to bear plural inspection
10) In addition, the person who judged that an ophthalmology specialist was unsuitable for wearing this contact lens

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuno Negishi

Organization

Keio University School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

35, Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-5363-3821

Email

fwic7788@mb.infoweb.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuno Negishi

Organization

Keio University School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

35, Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-5363-3821

Homepage URL


Email

fwic7788@mb.infoweb.ne.jp


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Ophthalmology,Keio University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Universal View Co., Ltd.

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

慶應義塾大学病院 (東京都)


Other administrative information

Date of disclosure of the study information

2015 Year 08 Month 17 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

2015 Year 07 Month 27 Day

Date of IRB


Anticipated trial start date

2015 Year 09 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

2015 Year 08 Month 13 Day

Last modified on

2016 Year 10 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021561


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name