UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053567 |
|---|---|
| Receipt number | R000061109 |
| Scientific Title | Longitudinal clinical study to evaluate myopic eyes of Japanese children |
| Date of disclosure of the study information | 2024/02/13 |
| Last modified on | 2024/02/07 17:22:35 |
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Basic information
Public title
Longitudinal clinical study to evaluate ocular morphological changes associated with myopia in Japanese children
Acronym
Longitudinal study of myopia
Scientific Title
Longitudinal clinical study to evaluate myopic eyes of Japanese children
Scientific Title:Acronym
Longitudinal study of myopia
Region
| Japan |
Condition
Condition
Myopia and myopic astigmatism
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the mechanism of myopia progression and the correlation between myopia and eye diseases with the evaluation of various parameters change of myopic eyes of Japanese children using orthokeratology lenses or spectacles.
Basic objectives2
Others
Basic objectives -Others
Basic research
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of retinal structure with axial elongation in 2 years
Key secondary outcomes
Change of corneal shape, corneal biomechanics, choroidal thickness and wavefront aberration with axial elongation in 2 years
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 7 | years-old | <= |
Age-upper limit
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- spherical power of subjective refraction is -4.00D ~ -0.50D
- cylindrical power of subjective refraction is -1.50D ~ 0.00D
- willing to come to the clinic for 2 years at least
- willing to wear orthokeratology lenses or single-vision spectacle
Key exclusion criteria
- having any eye diseases except ametropia
- having the history of any eye surgeries
- having the history of any treatments for myopia control (orthokeratology, multi focal contact lenses or spectacles. atropine etc.) in last 6 month
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Atsuya |
| Middle name | |
| Last name | Miki |
Organization
Aichi Medical University
Division name
Myopia research course
Zip code
480-1195
Address
1-1, Yazako Karimata, Nagakute, Aichi
TEL
0561-62-3311
a.miki.md@gmail.com
Public contact
Name of contact person
| 1st name | Hikaru |
| Middle name | |
| Last name | Asai |
Organization
Aichi Medical University
Division name
Myopia research course
Zip code
480-1195
Address
1-1, Yazako Karimata, Nagakute, Aichi
TEL
0561-62-3311
Homepage URL
h-hirata@menicon.co.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University
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
Aichi Medical University
Address
1-1, Yazako Karimata, Nagakute, Aichi
Tel
0561-62-3311
syomu@aichi-med-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
愛知医科大学眼科クリニックMiRAI
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 13 | 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
| 2022 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Various eye-related data will be measured over two-years for patients who visit Aichi Medical University Eye Center and undergo myopia correction using orthokeratology lenses or single vision spectacles. Measurements are carried out every six months. The measurement items are visual acuity, subjective/objective refractive power, anterior eye shape, intraocular pressure, corneal mechanics, axial length, central corneal thickness, wavefront aberration, choroidal thickness, and retinal thickness.
Management information
Registered date
| 2024 | Year | 02 | Month | 07 | Day |
Last modified on
| 2024 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061109
