UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000036019