UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032079 |
|---|---|
| Receipt number | R000036501 |
| Scientific Title | Study on safety and efficacy of pinhole contact lens to correct presbyopia with both eyes wearing |
| Date of disclosure of the study information | 2018/04/05 |
| Last modified on | 2018/10/03 17:18:53 |
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Basic information
Public title
Study on safety and efficacy of pinhole contact lens to correct presbyopia with both eyes wearing
Acronym
Safety and efficacy of pinhole contact lens with both eyes wearing
Scientific Title
Study on safety and efficacy of pinhole contact lens to correct presbyopia with both eyes wearing
Scientific Title:Acronym
Safety and efficacy of pinhole contact lens with both eyes wearing
Region
| Japan |
Condition
Condition
myopia or myopic astigmatism with presbyopia corrected good visual acuity
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of refractive and presbyopic correction with the pinhole contact lens(both eyes).
Basic objectives2
Safety,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(both eyes).
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 with both eyes
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) Patients with myopia and myopic astgmatism whose spherical equivalent of subjective refraction is between -1 and -9 dioptor as well as whose corrected visual acuity of 1.0 and pver
3) The astigmatism less than half of the spherical power
4) The patients whose both eyes can be observed and wearing
5) The patients who can come for examination on specified days
6) The patients who can wear pinhole contact lens daily for 3-8 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 < 10mm
7) Subjects who have ocular diseases affecting visual function except for refractive error and presbyoia
8) A pregnant woman, a woman nursing or woman with the plan of the pregnancy
9)The person who connot follow the instructions of the ophthalmologist
10) Extremely nervous persons
11) Person who are not able to undergo examinations
12) In addition, the person who are judged unsuitable to use pinhole contactlens by ophthalmologists
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miki Iwasaki |
Organization
RYOGOKU EYE CLINIC
Division name
Hospital Director
Zip code
Address
4-33-12, Ryogoku, Sumida-ku, Tokyo, JAPAN
TEL
03-5600-6886
mikiwasaki@aol.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miki Iwasaki |
Organization
RYOGOKU EYE CLINIC
Division name
Hospital Director
Zip code
Address
4-33-12, Ryogoku, Sumida-ku, Tokyo, JAPAN
TEL
03-5600-6886
Homepage URL
mikiwasaki@aol.com
Sponsor or person
Institute
RYOGOKU EYE CLINIC
Hospital Director
Institute
Department
Personal name
Funding Source
Organization
own supply
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
no
Name of secondary funder(s)
no
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
両眼眼科クリニック
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 05 | 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
| 2018 | Year | 03 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 03 | Day |
Last modified on
| 2018 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036501
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
