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

NCT ID: NCT06654180

Last Updated: 2024-10-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-21
• Study Completion Date: 2031-12-10

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.

Conditions

Myopia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Orthokeratology

To wear Orthokeratology at night to slow down progressing myopia

Group Type: ACTIVE_COMPARATOR

Orthokeratology

Intervention Type: DEVICE

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

To wear defocus-incorporated multiple segment lenses (DIMS) spectacles at daytime

Group Type: EXPERIMENTAL

defocus-incorporated multiple segment lenses (DIMS) spectacles

Intervention Type: DEVICE

It is the special lenses with peripheral lots of tiny segments of plus lenses around the center

defocus incorporated soft contact (DISK) lenses

To wear defocus incorporated soft contact (DISK) lenses at daytime

Group Type: EXPERIMENTAL

DISK

Intervention Type: DEVICE

SVS

single-vision spectacles (SVS)

To wear SVS at daytime and at night before sleep

Group Type: PLACEBO_COMPARATOR

Single-focus spectacles

Intervention Type: DEVICE

Myopic Glasses with mono-focus in each eye

Interventions

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.

Intervention Type: 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

Intervention Type: DEVICE

DISK

SVS

Intervention Type: DEVICE

Single-focus spectacles

Myopic Glasses with mono-focus in each eye

Intervention Type: DEVICE

Other Intervention Names

DIMS; DISK; SVS

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ningbo Eye Hospital

OTHER

Sponsor Role: collaborator

Kaikai QIU

OTHER

Sponsor Role: lead

Responsible Party

Kaikai QIU

Researcher

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Ningbo Eye Hospital

Ningbo, Zhejiang, China

Optometry department, Ningbo Eye Hospital

Ningbo, Zhejiang, China

Countries

China

Other Identifiers

MR-33-22-012252

Identifier Type: REGISTRY

Identifier Source: secondary_id

Southeast Eye Institute

Identifier Type: -

Identifier Source: org_study_id