UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on efficacy of pinhole contact lens to correct presbyopia
Title of the study (Brief title)	efficacy of pinhole contact lens
Region	Japan

Condition
Condition	myopia, myopic astigmatism and presbyopia
Classification by specialty	Ophthalmology Adult
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
Trial characteristics_2
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	Wearing 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	45 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) 45 years old and over 2) Patinets with myopia and myopic astigmatism whose spherical equivalent of subjective refraction is between -1 and -9 dioptor as well as whose corrected visual acuity of 1.0 and over 3) The astigmatism less than half of the spherical power 4) The patients whose both eyes can be observed 5) The patients who can come for examination on specified days 6) The patients who can wear pinhole contact lens daily for 3-4 hours 7) Soft CLs users 8) The patients who understand instructions and the explanation of the doctor, and can give a conscent
Key exclusion criteria	1) multifocal CLs users 2)toric CLs users 3) usershard CLs users 4) Subjects who cannot wear a contact lens 5) Corneal endothelial cell density < 2000/ mm2 6) Corneal diameter < 10 mm 7) Subjects who have ocular diseases affecting visual function except for refractive error and presbyopia 8) A pregnant woman, a woman nursing or woman with the plan of the pregnancy 9) The patient (AIDS, autoimmune disease) with the immune disease or diabetic 10) The person who cannot follow the instructions of the ophthalmologist 11) Extremely nervous persons 12) Person who are not able to undergo examinations 13) In addition, the person who are judged unsuitable to use pinhole contact lens by ophthalmologists
Target sample size	40

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	kazunonegishi@keio.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	kazunonegishi@keio.jp

Sponsor
Institute	Keio University School of Medicine Department of Ophthalmology
Institute
Department

Funding Source
Organization	own supply
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 26 Day
Anticipated trial start date	2018 Year 01 Month 15 Day
Last follow-up date	2018 Year 06 Month 21 Day
Date of closure to data entry	2018 Year 06 Month 21 Day
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	2017 Year 09 Month 26 Day
Last modified on	2018 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032286