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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031553
Receipt No. R000036019
Scientific Title Accommodation auxiliary effect by low addition power contact lens
Date of disclosure of the study information 2018/03/02
Last modified on 2019/09/02

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Basic information
Public title Accommodation auxiliary effect by low addition power contact lens
Acronym Accommodation auxiliary effect by low addition power contact lens
Scientific Title Accommodation auxiliary effect by low addition power contact lens
Scientific Title:Acronym Accommodation auxiliary effect by low addition power contact lens
Region
Japan

Condition
Condition Accommodative dysfunction
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the accommodation auxiliar effect by low addition power contact lens. Contribution to the improvement of accommodation dysfunction and corresponding quality of vision will be expected.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amplitude of accommodation
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Daily life with contact lens specifically prescribed for this study
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
39 years-old >=
Gender Male and Female
Key inclusion criteria Capable of wearing soft contact lens longer than 8 hours more than 5 times a week; Working with visual display terminals such as smartphone or computer more than 3 hours day; Ones who provided informed consent after receiving an explanation of the nature and possible consequences of the study
Key exclusion criteria Hard contact lens wearers; Having clinically significant anterior segment abnormalities; Orthokeratology lens wearers; Previous history of refractive surgery or cataract surgery; Having ocular or systemic disease; Pregnant or lactating females; Taking any medicine that may influence the accommodation; Ones considered as inappropriate subjects for the study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shizuka Koh
Organization Osaka University Graduate School of Medicine
Division name Department of Innovative Visual Science
Zip code
Address 2-2 Yamadaoka, Suita Osaka, 565-0871, Japan
TEL (+81)6-6879-3456
Email skoh@ophthal.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shizuka Koh
Organization Osaka University Graduate School of Medicine
Division name Department of Innovative Visual Science
Zip code
Address 2-2 Yamadaoka, Suita Osaka, 565-0871, Japan
TEL (+81)6-6879-3456
Homepage URL
Email skoh@ophthal.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Seed
Organization
Division
Category of Funding Organization Profit organization
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
2018 Year 03 Month 02 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 02 Month 14 Day
Date of IRB
2018 Year 03 Month 02 Day
Anticipated trial start date
2018 Year 03 Month 05 Day
Last follow-up date
2018 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 02 Day
Last modified on
2019 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036019

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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