Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Intervention | No Intervention | No intervention for myopia control | |
| Spectacle Lenses with Highly Aspherical Lenslets | Experimental | Wearing spectacle lenses with highly aspherical lenslets for myopia control |
|
| 0.01% Atropine | Experimental | Nightly use of 0.01% atropine eyedrops for myopia control |
|
| 0.05% Atropine | Experimental | Nightly use of 0.05% atropine eyedrops for myopia control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.01% atropine eye drops | Drug | Participants will use 0.01% atropine eyedrops nightly for myopia control. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in cycloplegic spherical equivalence | Measured by an auto-refractometer | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in axial length | Measured by an IOL-Master | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in choroid/retina thickness | Measured by SS-OCT | 2 years |
| Changes in BCVA | Best corrected visual acuity | 2 years |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangui He, Prof | Contact | +86 15000755422 | xianhezi@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Eye Disease Prevention and Treatment Center | Recruiting | Shanghai | Shanghai Municipality | China |
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| 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. | 2 years |
| Changes in IOP | Intraocular pressure | 2 years |
| Changes in AMP | Amplitude of Accommodation | 2 years |
| Changes in Stereopsis | Using Titmus Fly Test | 2 years |
| Changes in TBUT | Tear Film Break-Up Time | 2 years |
| Changes in anterior segment parameters | Measured by Pentacam | 2 years |
| Changes in Hemodynamic Parameters of the Ocular Fundus | Measured by SS-OCTA | 2 years |
| Compliance indicators | Daily wearing duration, wearing habits and patterns, frequency of eye drops use. | 2 years |
| Side Effects and Adverse Events | Incidence of glare, diplopia, blurred vision, photophobia, etc. | 2 years |