UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019591 |
|---|---|
| Receipt number | R000022531 |
| Scientific Title | The effect of orthokeratology on myopia progression |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2022/11/06 13:24:38 |
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Basic information
Public title
The effect of orthokeratology on myopia progression
Acronym
Myopia control with orthokeratology
Scientific Title
The effect of orthokeratology on myopia progression
Scientific Title:Acronym
Myopia control with orthokeratology
Region
| Japan |
Condition
Condition
myopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the refractive change and axial length elongation between children receiving orthokeratology treatment and those wearing single-vision spectacles
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
efficacy:
refractive error
axial length
Key secondary outcomes
safety:
corneal endothelial cell density
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
orthokeratology lens
every overnight wearing throughout the follow-up time
Interventions/Control_2
single-vision spectacles
everyday wearing as necessary throughout follow-up time
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
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) spherical equivalent error: from -4.5D to -1.0D in both eyes
2) astigmatism: <=1.5D in both eyes
3) anisometropia: <=1.5D
4) best-corrected visual acuity: >=0.00 logMAR units in both eyes
Key exclusion criteria
1) ocular diseases except refractive error
2) history of orthokeratology or use of medications
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Kinoshita |
Organization
Kyoto Prefectural University of Medicine
Division name
Ophthalmology
Zip code
602-8566
Address
465 Kajii-cho Kamigyo-ku Kyoto Japan
TEL
+81-75-251-5578
shigeruk@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Yo |
| Middle name | |
| Last name | Nakamura |
Organization
Kyoto Prefectural University of Medicine
Division name
Ophthalmology
Zip code
602-8566
Address
465 Kajii-cho Kamigyo-ku Kyoto Japan
TEL
+81-75-251-5578
Homepage URL
yonakamura0108@gmail.com
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
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
Institutional Review Board of Kyoto Prefectural University of Medicine
Address
465 Kajii-cho Kamigyo-ku Kyoto Japan
Tel
+81-75-251-5111
rinri@koto.kpu-m.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Partially published
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
90
Results
In orthokeratology group, myopia progression was suppressed compared in single vision spectacles group.
Results date posted
| 2021 | Year | 05 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
From 6 to 12 years old children
Participant flow
Subjects wore orthokeratology lens or single vision spectacles for 2 years. Last examination was performed after lens discontinuation peried in the orthokeratology group.
Adverse events
No adverse events
Outcome measures
refractive error change
change of axial length
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2012 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 08 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 01 | Day |
Last modified on
| 2022 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022531
