Comparing Myopia Control Efficacy in Children With 4 Methods: Orthokeratology, DIMS, DISK, and SVS.
- Conditions
- Myopia
- Registration Number
- NCT06654180
- Lead Sponsor
- Kaikai QIU
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
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Must agree to participate in the study
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Must have cycloplegic refraction with spherical equivalent refractive (SER)
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- 2.00 D ~ - 5.00 D (including the boundary values)
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Clinical diagnosis of astigmatism was ≤ 1.00D
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Must be able to have corrected visual acuity ≤ 0.00 logMAR of either eye
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Must be able to wear either of SVS/DIMS/DISC/Orthokeratology lenses and kept the same intervention for 12 month
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Must have the front cornea curve value between 41.00D~44.00D
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Must have axial length of the study eye between 23.00mm and 25.00mm at baseline
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (2)
Ningbo Eye Hospital
🇨🇳Ningbo, Zhejiang, China
Optometry department, Ningbo Eye Hospital
🇨🇳Ningbo, Zhejiang, China