Myopia
Conditions
Keywords
Myopia, Children
Brief summary
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.
Detailed description
orthokeratology and DISK are contact lenses, while DIMS and SVS are spectacles.
Interventions
DEVICEOrthokeratology
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.
DEVICEdefocus-incorporated multiple segment lenses (DIMS) spectacles
It is the special lenses with peripheral lots of tiny segments of plus lenses around the center
DEVICEDISK
SVS
DEVICESingle-focus spectacles
Myopic Glasses with mono-focus in each eye
Sponsors
Ningbo Eye Hospital
Kaikai QIU
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
* Must agree to participate in the study * Must have cycloplegic refraction with spherical equivalent refractive (SER) * \- 2.00 D \ - 5.00 D (including the boundary values) * Clinical diagnosis of astigmatism was ≤ 1.00D * Must be able to have corrected visual acuity ≤ 0.00 logMAR of either eye * Must be able to wear either of SVS/DIMS/DISC/Orthokeratology lenses and kept the same intervention for 12 month * Must have the front cornea curve value between 41.00D\ 44.00D * Must have axial length of the study eye between 23.00mm and 25.00mm at baseline
Exclusion criteria
* Dry eye * keratitis * Conjunctivitis * Clinical diagnosis of entropion * Clinical diagnosis of glaucoma * Clinical diagnosis of retinal lesions * Clinical diagnosis of amblyopia * Clinical diagnosis of optic media lesions (e.g., central thick corneal scars, cataract) * Clinical diagnosis of optic nerve dysfunction * Have medical history of atropine eyedrops (including 1% high concentration , 0.05%, 0.01% or other low concentration) * Have history of wearing peripheral defocus spectacles * Have history of wearing duo-focal soft contact lenses * Unable to follow up * Investigators consider to be not eligible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of axial length for 12-month (mm) | 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Spherical Equivalence Refraction (D) | 12 months | Changes of SER at 12-Month follow-up with cycloplegic refraction (Diopter, D) with the auto refractometer (Topcon KR-800, Topcon Corporation, Tokyo, Japan) |
| Dropout rate (%) | 12 months | The dropout rate of each group with the percentage (%) record by the formula =the dropout number versus total number of the each group \*100%. |
| Changes of ocular axial length at follow-up of 3 months (mm) | 3 months | Changes of ocular axial length at follow-up of 3 month from baseline with the IOLmaster 500(millimetre, mm) |
| Changes of ocular axial length at follow-up of 6 months (mm) | 6 months | Changes of ocular axial length at follow-up of 6 month from baseline with the IOLmaster 500(millimetre, mm) |
| Changes of ocular axial length at follow-up of 9 months (mm) | 9 months | Changes of ocular axial length at follow-up of 9 month from baseline with the IOLmaster 500(millimetre, mm) |
Countries
China
Outcome results
None listed