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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032079
Receipt No. 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

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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
Email 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
Email mikiwasaki@aol.com

Sponsor
Institute RYOGOKU EYE CLINIC
Hospital Director
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036501

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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