UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021897 |
|---|---|
| Receipt number | 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 09:10:03 |
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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
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
hidemasatorii@yahoo.co.jp
Sponsor or person
Institute
Minami Aoyama Eye Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025086
