NCT06654180

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

A Comparison of Myopia Control Efficacy in Children With Orthokeratology, Defocus Incorporated Multiple Segment (DIMS) Spectacles, Defocus Incorporated Soft Contact (DISK) Lenses, and Single-vision Spectacles for 12 Months

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Kaikai QIU · Academic / Other
• Sex: All
• Age: 8 Years – 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	defocus-incorporated multiple segment lenses (DIMS) spectacles	It is the special lenses with peripheral lots of tiny segments of plus lenses around the center
DEVICE	DISK	SVS
DEVICE	Single-focus spectacles	Myopic Glasses with mono-focus in each eye

Timeline

• Start date: 2022-10-21
• Primary completion: 2030-12-31
• Completion: 2031-12-10
• First posted: 2024-10-23
• Last updated: 2024-10-23

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated device study