🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06654180
Active, not recruiting Not applicable

Comparing Myopia Control Efficacy in Children With 4 Methods: Orthokeratology, DIMS, DISK, and SVS.

NCT06654180 · tracked via the Priya Life Science China tracker
Sponsor
Kaikai QIU
Phase
Not applicable
Started
2022-10-21
Last updated
2024-10-23

Condition(s) studied

Myopia

Investigational drug(s) / intervention(s)

Orthokeratologydefocus-incorporated multiple segment lenses (DIMS) spectaclesDISKSingle-focus spectacles

Orthokeratology: 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.

defocus-incorporated multiple segment lenses (DIMS) spectacles: It is the special lenses with peripheral lots of tiny segments of plus lenses around the center

DISK: SVS

Single-focus spectacles: Myopic Glasses with mono-focus in each eye

Study 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.

Eligibility

Sex
ALL
Min age
8 Years
Max age
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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Ningbo Eye Hospital Ningbo Zhejiang
Optometry department, Ningbo Eye Hospital Ningbo Zhejiang

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06654180 on ClinicalTrials.gov ↗ ← All trials in China