UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trials for evaluation of suppressive effect against myopia progression using the outdoor environment light and outdoor environment eyeglasses by their own expense
Acronym	Clinical trials for the outdoor environment light and the outdoor environment eyeglasses
Scientific Title	Clinical trials for evaluation of suppressive effect against myopia progression using the outdoor environment light and outdoor environment eyeglasses by their own expense
Scientific Title:Acronym	Clinical trials for the outdoor environment light and the outdoor environment eyeglasses
Region	Japan

Condition
Condition	myopia
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Outdoor environment is considered as one of the factors that suppress progression of myopia. The purpose of this study is evaluation for the suppressive effect against myopia progression using the outdoor environment light and the outdoor environment eyeglasses.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	axial length
Key secondary outcomes	cycloplegic refraction

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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Wearing the outdoor environment eyeglasses and using the outdoor environment light for two hours/day during two years
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Those who are in trouble with myopia. Those who can wear only the outdoor environment eyeglasses. Those who can use the outdoor environment light in accordance with the instructions of the doctor. Those who can follow the examination schedule. Those who can follow the direction of the doctor.
Key exclusion criteria	Those who are allergic to cycloplegic agent. Those who have narrow angle eye. Those who have any eye diseases and any systemic diseases. Those who have oral psoralen.
Target sample size	40

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Kazuo Tsubota
Organization	Minami Aoyama Eye Clinic
Division name	Ophthalmology
Zip code
Address	3-3-11-4F, Kitaaoyama, Minato-ku, Tokyo
TEL	03-5772-1451
Email	tsubota@z3.keio.jp

Public contact
1st name of contact person	1st name Middle name Last name Hidemasa Torii
Organization	Minami Aoyama Eye Clinic
Division name	Ophthalmology
Zip code
Address	3-3-11-4F, Kitaaoyama, Minato-ku, Tokyo
TEL	03-5772-1451
Homepage URL
Email	hidemasatorii@yahoo.co.jp

Sponsor
Institute	Minami Aoyama Eye Clinic
Institute
Department

Funding Source
Organization	no funding source
Organization
Division
Category of Funding Organization	Self funding
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	2016 Year 04 Month 18 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	Terminated
Date of protocol fixation	2016 Year 04 Month 01 Day
Date of IRB	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 18 Day
Last follow-up date	2019 Year 03 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	2016 Year 04 Month 13 Day
Last modified on	2019 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025086