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

NCT06654180 | Active Not Recruiting FDA Device

• 2 other identifiers: Southeast Eye InstituteMR-33-22-012252
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Myopia

Keywords

Myopia; Children

Outcome Measures

Primary Outcomes (1)

• Changes of axial length for 12-month (mm)

  The ocular axial length change at follow-up of 12-month from baseline with IOLmaster 500（IOLMaster 500, Carl Zeiss Meditec AG, Germany) in the unit of millimetre

  12 months

Secondary Outcomes (5)

• Changes of Spherical Equivalence Refraction (D)

  12 months

• Dropout rate (%)

  12 months

• Changes of ocular axial length at follow-up of 3 months (mm)

  3 months

• Changes of ocular axial length at follow-up of 6 months (mm)

  6 months

• Changes of ocular axial length at follow-up of 9 months (mm)

  9 months

Study Arms (4)

Orthokeratology

ACTIVE COMPARATOR

To wear Orthokeratology at night to slow down progressing myopia

Device: Orthokeratology

defocus-incorporated multiple segment lenses (DIMS) spectacles

EXPERIMENTAL

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

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

defocus incorporated soft contact (DISK) lenses

EXPERIMENTAL

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

Device: DISK

single-vision spectacles (SVS)

PLACEBO COMPARATOR

To wear SVS at daytime and at night before sleep

Device: Single-focus spectacles

Interventions

Orthokeratology 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.

Also known as: DIMS, DISK, SVS

Orthokeratology

defocus-incorporated multiple segment lenses (DIMS) spectacles DEVICE

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

defocus-incorporated multiple segment lenses (DIMS) spectacles

DISK DEVICE

SVS

defocus incorporated soft contact (DISK) lenses

Single-focus spectacles DEVICE

Myopic Glasses with mono-focus in each eye

single-vision spectacles (SVS)

Eligibility Criteria

• Age: 8 Years - 13 Years
• Gender Eligibility Details: All the genders are welcome to join the clinical trials. While those who is self-identified genders are eligible to participate while the record is not male or female.
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaikai QIU: lead
• Ningbo Eye Hospital: collaborator

Study Sites (2)

Ningbo Eye Hospital

Ningbo, Zhejiang, 315000, China

Location

Optometry department, Ningbo Eye Hospital

Ningbo, Zhejiang, 315000, China

Location

MeSH Terms

Conditions

Myopia

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 23, 2024
• Study Start: October 21, 2022
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 10, 2031
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)