Comparing Myopia Control Efficacy in Children With 4 Methods: Orthokeratology, DIMS, DISK, and SVS. (NCT06654180) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Comparing Myopia Control Efficacy in Children With 4 Methods: Orthokeratology, DIMS, DISK, and SVS.
China100 participantsStarted 2022-10-21
Plain-language 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.
Who can participate
Age range
8 Years – 13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.