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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018664
Receipt No. 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

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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
Institute Keio University School of Medicine
Institute
Department

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
URL(English) https://upload.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


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