Myopic Children
Conditions
Keywords
pre-myopic children, evaluation, intervention, comliance
Brief summary
Evaluate the efficacy, safety and wearing time compliance of novel plano spectacle lenses in delaying myopia onset in pre-myopic children and provide scientific basis for the development of myopia prevention strategies for children.
Detailed description
Children aged 6-9 years old with pre-myopia are randomly assigned to a control group and an intervention group at a 1:1 ratio. The intervention group uses novel plano spectacle lenses for at least 8 hours a day, and the control group doesn't receive any intervention. The efficacy of novel plano spectacle lenses in delaying myopia onset in pre-myopia children is evaluated by comparing the one-year incidence of myopia onset between intervention group and control group.
Interventions
DEVICENovel plano spectacle lenses
Use of novel plano spectacle lenses for at least 8 hours a day with objective wearing time measured by smart frame and objective outdoor time measured by smart bracelet.
Sponsors
Essilor International
Shanghai Eye Disease Prevention and Treatment Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Children aged 6-9 years old with pre-myopia are randomly assigned to a control group and an intervention group at a 1:1 ratio. The intervention group uses novel plano spectacle lenses for at least 8 hours a day, and the control group doesn't receive any intervention. The efficacy of novel plano spectacle lenses in delaying myopia onset in pre-myopia children is evaluated by comparing the one-year incidence of myopia onset between intervention group and control group.
Eligibility
Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
No
Inclusion criteria
* At the time of signing the informed consent form, the subject's age must be ≥6 years and \<10 years (6-9.99 years); * Both eyes are not myopic (SE\>-0.50D under cycloplegia) and at least one eye meets the pre-myopia condition ( -0.50D\< SE under cycloplegia ≤+0.75D); \[spherical equivalent (SE)=Sph+Cyl/2\] * Astigmatism ≤1.00D in each eye; * Difference in SER (Anisometropia) between the two eyes should not exceed ≤1.50D; * Unaided distance and near visual acuity of at least 0.1 logMAR in each eye ; * Be in good general health; * Be able to actively cooperate with the intervention plan and ophthalmological examination; * Normal binocular vision * At least one parent with SER ≤-3.00 D
Exclusion criteria
* Incapable of expressing consent * All categories of persons particularly protected by law * Subject in another study which might have an influence on vision or interfere with study assessment. * Previous use of other prevention solutions, such as but not limited to red light therapy within 6 months, Atropine and other interventions were used within 3 months; * History or presence of an ocular disease, systemic disease, strabismus or amblyopia or other binocular vision abnormalities, accommodation dysfunction, cataract and eye surgery; * Those who are allergic cycloplegic drugs; * Other reasons that the investigator considers inappropriate for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| One-year cumulative myopia incidence in either eye | From enrollment to the end of intervention for one year | One-year cumulative myopia incidence in either eye |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of unaided distance visual acuity | From enrollment to the end of intervention for one year | Changes of unaided distance visual acuity |
| Changes of accommodation function | From enrollment to the end of intervention for one year | Changes of accommodation function |
| Wearing time recorded in the questionnaire and smart frame | From enrollment to the end of intervention for one year | Wearing time recorded in the questionnaire and smart frame |
| Objective outdoor time recorded with smart bracelet | From enrollment to the end of intervention for one year | Objective outdoor time recorded with smart bracelet |
| Changes of spherical equivalent under cycloplegia | From enrollment to the end of intervention for one year | Changes of spherical equivalent under cycloplegia |
| Changes of axial length | From enrollment to the end of intervention for one year | Changes of axial length |
| Changes of choroidal thickness | From enrollment to the end of intervention for one year | Changes of choroidal thickness |
| Changes of visual acuity with novel spectacle lenses and Single Vision spectacle lenses | From enrollment to the end of intervention for one year | Changes of visual acuity with novel spectacle lenses and Single Vision spectacle lenses |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assessment of symptoms, complaints related to the study intervention, as reported by participants. | From enrollment to the end of intervention for one year | Assessment of symptoms, complaints related to the study intervention, as reported by participants. |
| Monocular best-corrected visual acuity (BCVA) | From enrollment to the end of intervention for one year | Monocular best-corrected visual acuity (BCVA) |
| Incidence and severity of adverse events (AEs) related to study intervention | From enrollment to the end of intervention for one year | Incidence and severity of adverse events (AEs) related to study intervention |
Countries
China
Outcome results
None listed