UMIN-CTR Clinical Trial

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

axial myopia, emmetropia eye

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

The change in axial length, refraction and peripheral optical quality

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tokyo Dental College

Institute

Department

Personal name

Organization

Japanese Society for Promotion of Science

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

11

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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