UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000021897
Receipt No. R000025086
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
Date of disclosure of the study information 2016/04/18
Last modified on 2019/04/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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
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/ctr_e/ctr_view.cgi?recptno=R000025086

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.