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

Kaikai QIU

Status: Active, not recruiting

Conditions: Myopia

Treatments: Device: Single-focus spectacles; Device: defocus-incorporated multiple segment lenses (DIMS) spectacles; Device: Orthokeratology; Device: DISK

Study type: Interventional

Funder types: Other

Identifiers

NCT06654180

Southeast Eye Institute

MR-33-22-012252 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

orthokeratology and DISK are contact lenses, while DIMS and SVS are spectacles.

Enrollment: 100 estimated patients

Sex: All

Ages: 8 to 13 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups, including a placebo group

Orthokeratology

Active Comparator group

Description:

To wear Orthokeratology at night to slow down progressing myopia

Treatment:

Device: Orthokeratology

defocus-incorporated multiple segment lenses (DIMS) spectacles

Experimental group

Description:

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

Treatment:

Device: defocus-incorporated multiple segment lenses (DIMS) spectacles

defocus incorporated soft contact (DISK) lenses

Experimental group

Description:

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

Treatment:

Device: DISK

single-vision spectacles (SVS)

Placebo Comparator group

Description:

To wear SVS at daytime and at night before sleep

Treatment:

Device: Single-focus spectacles