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Active, Not Recruiting

NCT Number: NCT06654180

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ningbo Eye Hospital, Ningbo, Zhejiang, China

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: DIMS, DISK, SVS

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

DISK

Device

SVS

Single-focus spectacles

Device

Myopic Glasses with mono-focus in each eye

Primary outcomes

  1. Changes of axial length for 12-month (mm)

    Time frame: 12 months

    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

Secondary outcomes

  1. Changes of Spherical Equivalence Refraction (D)

    Time frame: 12 months

    Changes of SER at 12-Month follow-up with cycloplegic refraction (Diopter, D) with the auto refractometer (Topcon KR-800, Topcon Corporation, Tokyo, Japan)

  2. Dropout rate (%)

    Time frame: 12 months

    The dropout rate of each group with the percentage (%) record by the formula =the dropout number versus total number of the each group *100%.

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

    Time frame: 3 months

    Changes of ocular axial length at follow-up of 3 month from baseline with the IOLmaster 500(millimetre, mm)

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

    Time frame: 6 months

    Changes of ocular axial length at follow-up of 6 month from baseline with the IOLmaster 500(millimetre, mm)

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

    Time frame: 9 months

    Changes of ocular axial length at follow-up of 9 month from baseline with the IOLmaster 500(millimetre, mm)

Sponsors and collaborators

Lead sponsor

Kaikai QIU

Other

Collaborators

  • Ningbo Eye Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2030
Study completion
2031
First posted
Oct 23, 2024
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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