Early-Onset Myopia Intervention Project

ConditionsMyopia Pre-myopia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age3-6

SponsorShanghai Eye Disease Prevention and Treatment Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

0.01% atropine eye drops
Drug
Participants will use 0.01% atropine eyedrops nightly for myopia control.
0.05% atropine eye drops
Drug
Participants will use 0.05% atropine eyedrops nightly for myopia control.
Spectacle lenses with highly aspherical lenslets
Device
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.

Treatment groups

508 Participants

are divided into 4 treatment groups

Group A: No InterventionNo intervention 0 interventions

Group B: Spectacle Lenses with Highly Aspherical LensletsExperimental treatment 1 intervention

Group C: 0.01% AtropineExperimental treatment 1 intervention

Group D: 0.05% AtropineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Changes in cycloplegic spherical equivalence

Measured by an auto-refractometer

Time frame

2 year

Secondary outcomes

Changes in axial length

Measured by an IOL-Master

Time frame

2 years

Proportion of subjects with non-rapid myopia progression

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.

Time frame

2 years

The duration of non-rapid myopia progression

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.

Time frame

2 years

Other outcomes

Changes in choroid/retina thickness

Measured by SS-OCT

Time frame

2 years

Changes in BCVA

Best corrected visual acuity

Time frame

2 years

Changes in IOP

Intraocular pressure

Time frame

2 years

Changes in AMP

Amplitude of Accommodation

Time frame

2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Eye Disease Prevention and Treatment Center

Lead sponsor

Source ClinicalTrials.gov

Apply now