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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029290
Receipt No. R000032286
Scientific Title Study on efficacy of pinhole contact lens to correct presbyopia
Date of disclosure of the study information 2017/09/27
Last modified on 2018/07/12

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Basic information
Public title Study on efficacy of pinhole contact lens to correct presbyopia
Acronym efficacy of pinhole contact lens
Scientific Title Study on efficacy of pinhole contact lens to correct presbyopia
Scientific Title:Acronym 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
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 kazunonegishi@keio.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 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)

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

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 27 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
2017 Year 09 Month 26 Day
Date of IRB
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

Other
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

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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