UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028553 |
|---|---|
| Receipt number | R000032676 |
| Scientific Title | Efficacy of 0.01% Atropine Ophthalmic Solution on Myopia Progression and Axial Elongation of the Eye in School Children with High- or Moderate-grade Myopia |
| Date of disclosure of the study information | 2017/09/15 |
| Last modified on | 2019/03/13 12:38:11 |
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Basic information
Public title
Efficacy of 0.01% Atropine Ophthalmic Solution on Myopia Progression and Axial Elongation of the Eye in School Children with High- or Moderate-grade Myopia
Acronym
Efficacy of 0.01% Atropine Ophthalmic Solution on Myopia Progression and Axial Elongation of the Eye in School Children with High- or Moderate-grade Myopia
Scientific Title
Efficacy of 0.01% Atropine Ophthalmic Solution on Myopia Progression and Axial Elongation of the Eye in School Children with High- or Moderate-grade Myopia
Scientific Title:Acronym
Efficacy of 0.01% Atropine Ophthalmic Solution on Myopia Progression and Axial Elongation of the Eye in School Children with High- or Moderate-grade Myopia
Region
| Japan |
Condition
Condition
high- or moderate-grade myopia
Classification by specialty
| Ophthalmology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the efficacy of 0.01% atropine ophthalmic solution on myopia progression and axial elongation of the eye in the school children diagnosed with high- or moderate-grade myopia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in objectively-measured spherical equivalent refraction and axial length of the eye during the follow-up period of 12 months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
daily application of 0.01% atropine ophthalmic solution to the both eyes for 12 months
Interventions/Control_2
spectacle correction only
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
(1) Children aged 6 to 12 years at the time of consent
(2) Children with spherical equivalent refraction of -4.50 to-9.00 D in each eye
(3) Children with anisometropia within 1.50 D.
(4) Children with astigmatism within +/-1.50 D
(5) Children with corrected visual acuity of at least 1.0
(6) Children with intraocular pressure equal
to or lower than 21mmHg
(7) Children capable of undergoing cycloplegia
(8) Children who can undergo outpatient examinations per protocol
(9) Written informed consent to participate in the study obtained from the child personally and a person with parental authority
Key exclusion criteria
(1) Children with abnormal binocular function
(2) Children with amblyopia or manifest strabismus
(3) Children with ocular disorders other than myopia
(4) Children with ocular or systemic disorders that potentially affect myopia or refractive power
(5) Children who have received previous treatment for myopia control that included atropine therapy, bifocal lenses, progressive lenses, and Ortho-K.
(6) Children with a history of cardiovascular or respiratory disease
(7) Children who have received pharmacotherapy for asthma in the past year
(8) Children with allergy to atropine, cyclopentolate, or benzalkonium
(9) Children who cannot use eye drops
(10) Children who plans to use contact lenses during the follow-up period
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Hasebe |
Organization
Kawasaki Medical School
Division name
Department of Ophthalmology 2
Zip code
700-8505
Address
2-6-1 Nakasange, Kita-ku, Okayama
TEL
086-225-2111
shasebe2009@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hasebe |
| Middle name | |
| Last name | Satoshi |
Organization
Kawasaki Medical School
Division name
Department of Ophthalmology 2
Zip code
700-8558
Address
2-6-1 Nakasange, Kita-ku, Okayama
TEL
086-225-2111
Homepage URL
https://g.kawasaki-m.ac.jp/dept/ganka/ekigaku
shasebe2009@yahoo.co.jp
Sponsor or person
Institute
Kawasaki Medical School
Department of Ophthalmology 2
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology, and Kawasaki Medical School
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
086-235-6938
mae6605@adm.okayama-u.ac.jp
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
川崎医科大学総合医療センター（岡山県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 06 | Day |
Last modified on
| 2019 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032676
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| Registered date | File name |
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