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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016869
Receipt No. R000019580
Scientific Title Effect of pupil size on uncorrected visual acuity and subjective refraction in myopic eyes.
Date of disclosure of the study information 2015/03/22
Last modified on 2015/07/26

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Basic information
Public title Effect of pupil size on uncorrected visual acuity and subjective refraction in myopic eyes.
Acronym Pupil size and UCVA and refraction
Scientific Title Effect of pupil size on uncorrected visual acuity and subjective refraction in myopic eyes.
Scientific Title:Acronym Pupil size and UCVA and refraction
Region
Japan

Condition
Condition Myopic eyes
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the effects of pupil size on uncorrected visual acuity (UCVA) and subjective refraction in myopic eyes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes UDVA, subjectve refraction
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 artificial pupils
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
20 years-old <=
Age-upper limit
45 years-old >=
Gender Male and Female
Key inclusion criteria Myopic eyes
Key exclusion criteria No ophthalmic diseases other than refractive errors
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidenaga Kobashi
Organization University of Kitasato School of Medicine
Division name Department of Ophthalmology
Zip code
Address 1-15-1 Kitasato, Sagamihara, Kanagawa, 228-8555, Japan
TEL +81-42-778-9012
Email himon@hotmail.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidenaga Kobashi
Organization University of Kitasato School of Medicine
Division name Department of Ophthalmology
Zip code
Address 1-15-1 Kitasato, Sagamihara, Kanagawa, 228-8555, Japan
TEL +81-42-778-9012
Homepage URL
Email himon@hotmail.co.jp

Sponsor
Institute University of Kitasato School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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
2015 Year 03 Month 22 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 10 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 22 Day
Last modified on
2015 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019580

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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