Myopia, Pre-myopia
Conditions
Brief summary
The prevalence of myopia among children has been increasing year by year, which has become a globle public health issue. Studies have shown that defocusing lenses and atroping eyedrops can control the progression of myopia, but there is little evidence of its efficacy in myopia intervention of young pre-schoolers who will face a greater risk of progression to high myopia later in life. Therefore, this study aims to evaluate the effectiveness and safety of spectacle lenses with highly aspherical lenslets (Essilor's Stellest) , as well as 0.01% and 0.05% low concentration atropine eyedrops in myopia intervention among young children aged 3-6.
Interventions
Participants will use 0.05% atropine eyedrops nightly for myopia control.
Participants will use 0.01% atropine eyedrops nightly for myopia control.
DEVICESpectacle lenses with highly aspherical lenslets
These are a special type of eyeglass lenses designed primarily to slow down the progression of myopia (nearsightedness) in children. The center of the lens provides a clear correction for distance vision, just like regular glasses. The surrounding area contains hundreds of tiny, invisible, and highly aspherical (complex curved) microlenses. These microlenses create a special optical effect. While the child looks straight ahead clearly, peripheral light rays are focused in front of the retina. This is called myopic defocus. Research suggests that this myopic defocus signal helps to control the excessive elongation of the eyeball, which is the main cause of myopia getting worse.
Sponsors
Shanghai Eye Disease Prevention and Treatment Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* Age 3-6 years, gender unrestricted; * Bilateral cycloplegic spherical equivalent (SE) ≤ +0.75 D, astigmatism ≤-2.5 D, anisometropia ≤2.5 D; * Best corrected visual acuity: ≥0.5 for ages 3-5, ≥0.7 for age 6; * Accept regular follow-up, written informed consent from guardians, verbal informed consent from children; * Possess normal thinking and language communication skills, and can actively cooperate to wear spectacles as required.
Exclusion criteria
* Existence of strabismus or amblyopia or other binocular vision abnormalities, accommodation dysfunction, cataract and history of eye surgery; * Any ocular or systemic disease that may affect vision and refractive development (e.g., Keratoconus, Marfan syndrome, retinopathy of prematurity, etc.); * Current or previous use of other treatments for myopia intervention, such as pharmacological (atropine) and optical (orthokeratology lenses or DIMS spectacle lenses) approaches, interrupt use for at least 4 weeks; * Allergy or contraindication to cycloplegic drugs; * Epilepsy or other mental disorders unable to expressing consent; * Other conditions deemed unsuitable for participation by the researcher.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in cycloplegic spherical equivalence | 2 year | Measured by an auto-refractometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with non-rapid myopia progression | 2 years | Rapid myopia progression is defined as: spherical equivalence increase (become less positive or more negative refractive error) of any eye ≥ 0.5 D in half a year. |
| The duration of non-rapid myopia progression | 2 years | Rapid myopia progression is defined as: spherical equivalence increase (become less positive or more negative refractive error) of any eye ≥ 0.5 D in half a year. |
| Changes in axial length | 2 years | Measured by an IOL-Master |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in AMP | 2 years | Amplitude of Accommodation |
| Changes in Stereopsis | 2 years | Using Titmus Fly Test |
| Changes in TBUT | 2 years | Tear Film Break-Up Time |
| Changes in anterior segment parameters | 2 years | Measured by Pentacam |
| Changes in Hemodynamic Parameters of the Ocular Fundus | 2 years | Measured by SS-OCTA |
| Compliance indicators | 2 years | Daily wearing duration, wearing habits and patterns, frequency of eye drops use. |
| Side Effects and Adverse Events | 2 years | Incidence of glare, diplopia, blurred vision, photophobia, etc. |
| Changes in choroid/retina thickness | 2 years | Measured by SS-OCT |
| Changes in BCVA | 2 years | Best corrected visual acuity |
| Changes in IOP | 2 years | Intraocular pressure |
Countries
China
Contacts
Primary ContactXiangui He, Prof
Outcome results
None listed