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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014362
Receipt No. R000016449
Scientific Title Examination of suppressive effect by combined treatment of orthokeratology and atropine 0.01% ophthalmic solution on myopia progression
Date of disclosure of the study information 2014/06/24
Last modified on 2020/08/25

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Basic information
Public title Examination of suppressive effect by combined treatment of orthokeratology and atropine 0.01% ophthalmic solution on myopia progression
Acronym Preventing myopia progression which combined orthokeratology and atropine 0.01% ophthalmic solution
Scientific Title Examination of suppressive effect by combined treatment of orthokeratology and atropine 0.01% ophthalmic solution on myopia progression
Scientific Title:Acronym Preventing myopia progression which combined orthokeratology and atropine 0.01% ophthalmic solution
Region
Japan

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

Objectives
Narrative objectives1 To investigate the additive effects of orthokeratology and atropine 0.01% ophthalmic solution in preventing axial length elongation in children with myopia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Efficacy: Increase in axial length over a 2-year period
Key secondary outcomes Safty: Decrease in corneal endothelial cell density over a 2-year period
Efficacy: Increase in axial length over a 1-year period
Safty: Decrease in corneal endothelial cell density over a 1-year period

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Orthokeratology contact lens
Interventions/Control_2 Atropine 0.01% ophthalmic solution
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
8 years-old <=
Age-upper limit
12 years-old >=
Gender Male and Female
Key inclusion criteria 1) Cycloplegic spherical equivalent refractive error of -1.00 to -6.00 D in both eyes
2) Astigmatism of less than 1.50 D in both eyes
3) Anisometropia of less than 1.50 D
4) Best corrected visual acuity of more than 1.0 in both eyes

Key exclusion criteria 1) Eye disorders such as strabismus and amblyopia
2) Systemic disorders such as cardiac or respiratory illness
3) Birth weight of less than 1500 g
4) History of hypersensitivity to atropine
5) Using of orthokeratology and/or atropine ophthalmic solutions
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Nozomi
Middle name
Last name Kinoshita
Organization Saitama Medical Center, Jichi Medical University
Division name Department of Ophthalmology
Zip code 330-8503
Address 1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama 330-8503, Japan
TEL 048-647-2111
Email nozomik@omiya.jichi.ac.jp

Public contact
Name of contact person
1st name Nozomi
Middle name
Last name Kinoshita
Organization Saitama Medical Center, Jichi Medical University
Division name Department of Ophthalmology
Zip code 330-8503
Address 1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama 330-8503, Japan
TEL 048-647-2111
Homepage URL http://researchmap.jp/nozomik1012/
Email nozomik@omiya.jichi.ac.jp

Sponsor
Institute Department of Ophthalmology, Saitama Medical Center, Jichi Medical University
Institute
Department

Funding Source
Organization JSPS KAKENHI Grant Number JP26462646 from the Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Konno Eye Clinic
Omiya Hamada Eye Clinic
Name of secondary funder(s) Universal View Co., Ltd.


IRB Contact (For public release)
Organization The ethical committee at Saitama Medical Centre, Jichi Medical University
Address 1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama 330-8503, Japan
Tel 048-647-2111
Email ycanda-tky@umin.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 こんの眼科/Konno Eye Clinic
大宮はまだ眼科/Omiya Hamada Eye Clinic

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 24 Day

Related information
URL releasing protocol http://researchmap.jp/nozomik1012/
Publication of results Published

Result
URL related to results and publications https://doi.org/10.1038/s41598-020-69710-8
Number of participants that the trial has enrolled 80
Results Dataset analyzed in the above paper
https://doi.org/10.17632/y58rh8bfkv.7
Results date posted
2019 Year 03 Month 29 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 07 Month 29 Day
Baseline Characteristics Described in the paper published by Scientific Reports.
https://doi.org/10.1038/s41598-020-69710-8
Participant flow Described in the paper published by Scientific Reports.
https://doi.org/10.1038/s41598-020-69710-8
Adverse events Described in the paper published by Scientific Reports.
https://doi.org/10.1038/s41598-020-69710-8
Outcome measures Described in the paper published by Scientific Reports.
https://doi.org/10.1038/s41598-020-69710-8
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 06 Month 20 Day
Date of IRB
2014 Year 06 Month 20 Day
Anticipated trial start date
2014 Year 06 Month 30 Day
Last follow-up date
2019 Year 03 Month 28 Day
Date of closure to data entry
2019 Year 03 Month 28 Day
Date trial data considered complete
2019 Year 03 Month 28 Day
Date analysis concluded
2019 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 06 Month 24 Day
Last modified on
2020 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016449

Research Plan
Registered date File name
2017/12/24 Trial protocol (Kinoshita).docx

Research case data specifications
Registered date File name
2018/03/04 Data set (Kinoshita).xlsx

Research case data
Registered date File name
2019/12/03 Data set (Kinoshita).xlsx


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