The goal of this clinical trial is to learn if 3 optical interventions（DIMS, DISC and orthokeratology) to control myopia have different efficacy to slow myopia progression in children when the control is single focus spectacles(SVS). It will also learn about the safety of all 4 interventions. The main questions it aims to answer are: Does orthokeratology slows the progressing myopia more significant than the DIMS or DISK? What medical problems do participants have when taking orthokeratology, DIMS and DISK? Researchers will compare all the 3 interventions to a placebo (SVS) to see if 3 interventions has significant difference in slow the axial length elongation as well as the refraction changes. Participants will: Take orthokeratology, DIMS, DISK or SVS every day for 12 months Visit the clinic once every 3 months for checkups and tests.
orthokeratology and DISK are contact lenses, while DIMS and SVS are spectacles.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Orthokeratology is to a rigid contact lens with reverse design to flat the central cornea to correct the myopia, which is to use at night during sleep; DIMS and SVS are both spectacles to wear at daytime; DIMS has many tiny lenses at peripheral of the big lenses to make the peripheral retina myopic defocus during the daytime; SVS has only one focus while DIMS has many focuses made by the tiny segments lenses around the peripheral vision fields; DISK is a soft contact lens with peripheral myopic power design to make the myopic eyes defocus at peripheral during the daytime.
It is the special lenses with peripheral lots of tiny segments of plus lenses around the center
SVS
Myopic Glasses with mono-focus in each eye
Ningbo Eye Hospital
Ningbo, Zhejiang, China
Optometry department, Ningbo Eye Hospital
Ningbo, Zhejiang, China
Changes of axial length for 12-month (mm)
The ocular axial length change at follow-up of 12-month from baseline with IOLmaster 500（IOLMaster 500, Carl Zeiss Meditec AG, Germany) in the unit of millimetre
Time frame: 12 months
Changes of Spherical Equivalence Refraction (D)
Changes of SER at 12-Month follow-up with cycloplegic refraction (Diopter, D) with the auto refractometer (Topcon KR-800, Topcon Corporation, Tokyo, Japan)
Time frame: 12 months
Dropout rate (%)
The dropout rate of each group with the percentage (%) record by the formula =the dropout number versus total number of the each group \*100%.
Time frame: 12 months
Changes of ocular axial length at follow-up of 3 months (mm)
Changes of ocular axial length at follow-up of 3 month from baseline with the IOLmaster 500(millimetre, mm)
Time frame: 3 months
Changes of ocular axial length at follow-up of 6 months (mm)
Changes of ocular axial length at follow-up of 6 month from baseline with the IOLmaster 500(millimetre, mm)
Time frame: 6 months
Changes of ocular axial length at follow-up of 9 months (mm)
Changes of ocular axial length at follow-up of 9 month from baseline with the IOLmaster 500(millimetre, mm)
Time frame: 9 months
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