Clinical trial NCT06654180: Comparing Myopia Control Efficacy in Children With 4 Methods: Orthokeratology, DIMS, DISK, and SVS.
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myopia
Keywords: Myopia
Children
Lead sponsor: Fuzhou Southeast Institute of Visual Ophthalmology
Sponsor class: OTHER
Collaborators: name: Ningbo Eye Hospital
First posted: 2024-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes of axial length for 12-month (mm)
timeFrame: 12 months
Secondary outcomes:
measure: Changes of Spherical Equivalence Refraction (D)
timeFrame: 12 months
measure: Dropout rate (%)
timeFrame: 12 months
measure: Changes of ocular axial length at follow-up of 3 months (mm)
timeFrame: 3 months
measure: Changes of ocular axial length at follow-up of 6 months (mm)
timeFrame: 6 months
measure: Changes of ocular axial length at follow-up of 9 months (mm)
timeFrame: 9 months
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo Eye Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Optometry department, Ningbo Eye Hospital
state: Zhejiang
Study officials:
References: