UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029290 |
|---|---|
| Receipt number | 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 10:39:35 |
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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
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
kazunonegishi@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Department of Ophthalmology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032286
