UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028768 |
|---|---|
| Receipt number | R000032904 |
| Scientific Title | Suppression of myopia progression by low dose atropine |
| Date of disclosure of the study information | 2017/08/25 |
| Last modified on | 2017/08/22 10:11:50 |
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Basic information
Public title
Suppression of myopia progression by low dose atropine
Acronym
Suppression of myopia progression by low dose atropine
Scientific Title
Suppression of myopia progression by low dose atropine
Scientific Title:Acronym
Suppression of myopia progression by low dose atropine
Region
| Japan |
Condition
Condition
Childhood Myopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study on suppression effect of childhood myopia progression with low dose atropine(0.01%).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Myopia progression at 4 year
Cycloplegic subjective refraction
Axial length
Key secondary outcomes
Distance best-corrected visual acuity logMAR
Near visual acuity was assessed using best corrected distance spectacle correction with a reduced logMAR reading chart
Pupil diameter
Accommodation amplitude
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
0.01% atropine
Once a day
4 year
Single vision lenses
Interventions/Control_2
Single vision lenses
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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Spherical equivalent -1.50D~-4.50D
Astigmatism of less than 1.5D
Key exclusion criteria
A case with ocular disease other than myopia
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyoko Ohno-Matsui |
Organization
Tokyo Medical and Dental University
Division name
Ophthalmology&Visual Science
Zip code
Address
1-5-45 Yushima,Bunkyo-ku,Tokyo,Japan113-8519
TEL
03-3813-6111
k.ohno.oph@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Nishiyama |
Organization
Tokyo Medical and Dental University
Division name
Ophthalmology&Visual Science
Zip code
Address
1-5-45 Yushima,Bunkyo-ku,Tokyo,Japan113-8519
TEL
03-3813-6111
Homepage URL
ynishiyama-tmd@umin.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
YES
Study ID_1
M2000-1638
Org. issuing International ID_1
Tokyo Medical and Dental University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京医科歯科大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 22 | Day |
Last modified on
| 2017 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032904
