UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006743 |
|---|---|
| Receipt number | R000007967 |
| Scientific Title | Progression of Axial Myopia in Childhood is Associated with Blurring of Peripheral Retinal Image due to Hyperopic Defocus, not due to Higher-order Aberration |
| Date of disclosure of the study information | 2011/11/19 |
| Last modified on | 2011/11/18 01:58:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Progression of Axial Myopia in Childhood is Associated with Blurring of Peripheral Retinal Image due to Hyperopic Defocus, not due to Higher-order Aberration
Acronym
Progression of Axial Myopia in Childhood is Associated with Blurring of Peripheral Retinal Image due to Hyperopic Defocus, not due to Higher-order Aberration
Scientific Title
Progression of Axial Myopia in Childhood is Associated with Blurring of Peripheral Retinal Image due to Hyperopic Defocus, not due to Higher-order Aberration
Scientific Title:Acronym
Progression of Axial Myopia in Childhood is Associated with Blurring of Peripheral Retinal Image due to Hyperopic Defocus, not due to Higher-order Aberration
Region
| Japan |
Condition
Condition
axial myopia, emmetropia eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relation between the axial elongation, myopic progression and the peripheral optical quality including relative peripheral defocus (RPD) and higher-order aberration (HOA).
Basic objectives2
Others
Basic objectives -Others
This study will present the first investigation on the peripheral retinal image quality in relation to myopia progression in normal children using double-pass retinal image measurement, which analyzed both of the defocus and the PSF. Although the peripheral PSF which represents its higher-order aberration degrades as the off-axis angle increases, the hyperopic RPD has more influence on the myopic progression. The amount of hyperopic RPD varied with individual, which potentially implied that the customized RPD correction might be the prophylactic effect against myopic progression.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The change in axial length, refraction and peripheral optical quality
Key secondary outcomes
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
| 8 | years-old | <= |
Age-upper limit
| 20 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Normal children without the ocular history except refractive error.
Key exclusion criteria
Children with binocular vision conditions with strabismus, any ocular or systemic condition associated with myopia (e.g., Marfan syndrome, retinopathy of prematurity, etc), a history of orthokeratology lens wear, bifocal or progressive addition spectacles in the past 12 months, atropine treatment for myopia control, or known allergy to tropicamide or phenylephrine were excluded from this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yamaguchi Takefumi |
Organization
Tokyo Dental College
Division name
Department of Ophthalmology
Zip code
Address
5-11-13, Sugano, Ichikawa, Chiba, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yamaguchi Takefumi |
Organization
Tokyo Dental College
Division name
Department of Ophthalmology
Zip code
Address
TEL
Homepage URL
yama19770614@hotmail.com
Sponsor or person
Institute
Tokyo Dental College
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 11 | Month | 19 | 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
Completed
Date of protocol fixation
| 2011 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
the amount of the hyperopic RPD varied among the subjects in this study. Moreover, the amount of hyperopic RPD decreased in some children although there was not statistically difference in the change of hyperopic RPD among the emmetropic and myopic eyes, which may be the possible mechanism of refraction control in children. That is, emmetropization is controlled by the amount of RPD and myopic progression may be induced by the disruption of the physiological emmetropization mechanism.
Management information
Registered date
| 2011 | Year | 11 | Month | 18 | Day |
Last modified on
| 2011 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007967
