NCT06654180

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

Active, enrolled NA Last updated 23 October 2024

What this trial tests

NA trial testing Orthokeratology in Myopia in 100 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

21 October 2022

Primary endpoint
31 December 2030

10 December 2031

Quick facts

Lead sponsor	Kaikai QIU
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	100
Start date	21 October 2022
Primary completion	31 December 2030
Estimated completion	10 December 2031
Sites	2 locations across China

Drugs / interventions tested

• Orthokeratology
• defocus-incorporated multiple segment lenses (DIMS) spectacles
• DISK
• Single-focus spectacles

Conditions studied

• Myopia — all drugs for Myopia →

Sponsor

Kaikai QIU

Who can join

Adults 8 to 13, any sex, with Myopia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.