UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016480 |
|---|---|
| Receipt number | R000019101 |
| Scientific Title | Efficacy of pinhole contact lens with no refractive power |
| Date of disclosure of the study information | 2015/02/09 |
| Last modified on | 2016/10/25 17:49:30 |
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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 | 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
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
9
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
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
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
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
慶應義塾大学医学部眼科学教室 （東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 09 | 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
| 2014 | Year | 12 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 09 | 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=R000019101
