UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006743
Receipt No. 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

* 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
Email

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
Email yama19770614@hotmail.com

Sponsor
Institute Tokyo Dental College
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007967

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.