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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: Orthokeratology; Device: defocus-incorporated multiple segment lenses (DIMS) spectacles; Device: DISK; Device: Single-focus spectacles

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Ningbo, Zhejiang, China, 315000
      • Ningbo Eye Hospital
    • Ningbo, Zhejiang, China, 315000
      • Optometry department, Ningbo Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Orthokeratology; To wear Orthokeratology at night to slow down progressing myopia	Device: 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.; Other Names: SVS; DIMS; DISK
Experimental: defocus-incorporated multiple segment lenses (DIMS) spectacles; To wear defocus-incorporated multiple segment lenses (DIMS) spectacles at daytime	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
Experimental: defocus incorporated soft contact (DISK) lenses; To wear defocus incorporated soft contact (DISK) lenses at daytime	Device: DISK; SVS
Placebo Comparator: single-vision spectacles (SVS); To wear SVS at daytime and at night before sleep	Device: Single-focus spectacles; Myopic Glasses with mono-focus in each eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Spherical Equivalence Refraction (D)	Changes of SER at 12-Month follow-up with cycloplegic refraction (Diopter, D) with the auto refractometer (Topcon KR-800, Topcon Corporation, Tokyo, Japan)	12 months
Dropout rate (%)	The dropout rate of each group with the percentage (%) record by the formula =the dropout number versus total number of the each group *100%.	12 months
Changes of ocular axial length at follow-up of 3 months (mm)	Changes of ocular axial length at follow-up of 3 month from baseline with the IOLmaster 500(millimetre, mm)	3 months
Changes of ocular axial length at follow-up of 6 months (mm)	Changes of ocular axial length at follow-up of 6 month from baseline with the IOLmaster 500(millimetre, mm)	6 months
Changes of ocular axial length at follow-up of 9 months (mm)	Changes of ocular axial length at follow-up of 9 month from baseline with the IOLmaster 500(millimetre, mm)	9 months

Collaborators and Investigators

• Sponsor: Kaikai QIU
• Collaborators: Ningbo Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2022
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 10, 2031

Study Registration Dates

• First Submitted: October 16, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): October 23, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Children; Myopia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: Southeast Eye Institute; MR-33-22-012252 (Registry Identifier: Research Committee of China Medical Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The explanation why IPD will not be shared is that almost all the data to be obtained is on another clinic center with another external site. The data is confidential to obtain to outside system with complete details.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes