Unique ID issued by UMIN | UMIN000014362 |
---|---|
Receipt number | 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 21:42:29 |
Examination of suppressive effect by combined treatment of orthokeratology and atropine 0.01% ophthalmic solution on myopia progression
Preventing myopia progression which combined orthokeratology and atropine 0.01% ophthalmic solution
Examination of suppressive effect by combined treatment of orthokeratology and atropine 0.01% ophthalmic solution on myopia progression
Preventing myopia progression which combined orthokeratology and atropine 0.01% ophthalmic solution
Japan |
Myopia
Ophthalmology |
Others
NO
To investigate the additive effects of orthokeratology and atropine 0.01% ophthalmic solution in preventing axial length elongation in children with myopia.
Safety,Efficacy
Confirmatory
Pragmatic
Efficacy: Increase in axial length over a 2-year period
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
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
YES
NO
Institution is considered as a block.
YES
Numbered container method
2
Prevention
Medicine | Device,equipment |
Orthokeratology contact lens
Atropine 0.01% ophthalmic solution
8 | years-old | <= |
12 | years-old | >= |
Male and Female
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
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
80
1st name | Nozomi |
Middle name | |
Last name | Kinoshita |
Saitama Medical Center, Jichi Medical University
Department of Ophthalmology
330-8503
1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama 330-8503, Japan
048-647-2111
nozomik@omiya.jichi.ac.jp
1st name | Nozomi |
Middle name | |
Last name | Kinoshita |
Saitama Medical Center, Jichi Medical University
Department of Ophthalmology
330-8503
1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama 330-8503, Japan
048-647-2111
http://researchmap.jp/nozomik1012/
nozomik@omiya.jichi.ac.jp
Department of Ophthalmology, Saitama Medical Center, Jichi Medical University
JSPS KAKENHI Grant Number JP26462646 from the Japan Society for the Promotion of Science
Japanese Governmental office
Japan
Konno Eye Clinic
Omiya Hamada Eye Clinic
Universal View Co., Ltd.
The ethical committee at Saitama Medical Centre, Jichi Medical University
1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama 330-8503, Japan
048-647-2111
ycanda-tky@umin.ac.jp
NO
こんの眼科/Konno Eye Clinic
大宮はまだ眼科/Omiya Hamada Eye Clinic
2014 | Year | 06 | Month | 24 | Day |
http://researchmap.jp/nozomik1012/
Published
https://doi.org/10.1038/s41598-020-69710-8
80
Dataset analyzed in the above paper
https://doi.org/10.17632/y58rh8bfkv.7
2019 | Year | 03 | Month | 29 | Day |
2020 | Year | 07 | Month | 29 | Day |
Described in the paper published by Scientific Reports.
https://doi.org/10.1038/s41598-020-69710-8
Described in the paper published by Scientific Reports.
https://doi.org/10.1038/s41598-020-69710-8
Described in the paper published by Scientific Reports.
https://doi.org/10.1038/s41598-020-69710-8
Described in the paper published by Scientific Reports.
https://doi.org/10.1038/s41598-020-69710-8
Completed
2014 | Year | 06 | Month | 20 | Day |
2014 | Year | 06 | Month | 20 | Day |
2014 | Year | 06 | Month | 30 | Day |
2019 | Year | 03 | Month | 28 | Day |
2019 | Year | 03 | Month | 28 | Day |
2019 | Year | 03 | Month | 28 | Day |
2019 | Year | 06 | Month | 30 | Day |
2014 | Year | 06 | Month | 24 | Day |
2020 | Year | 08 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016449
Research Plan | |
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Registered date | File name |
2017/12/24 | Trial protocol (Kinoshita).docx |
Research case data specifications | |
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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 |