UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of pinhole contact lens with no refractive power
Title of the study (Brief title)	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	Kazuno Negishi
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
Address	35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3821
Email	fwic7788@mb.infoweb.ne.jp

Public contact
Name of contact person	Kazuno Negishi
Organization	Keio University School of Medicine
Division name	Department of Ophthalmology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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