Myopia, Pre-myopia
Conditions
Keywords
pre-myopia, young children, AI-assisted DIMS-based spectacle lens
Brief summary
Pre-myopia refers to a condition in which children have not yet developed myopia but exhibit insufficient hyperopic reserve (≤ +0.75 D). This is particularly relevant for young children aged 6 years and under; if their hyperopic reserve is depleted prematurely and they progress into the pre-myopia stage, the likelihood of developing myopia or even high myopia in the future becomes extremely high. Therefore, this study plans to conduct a parallel-design, open-label, single-center randomized controlled clinical trial to evaluate the efficacy and safety of artificial intelligence-assisted defocus incorporated multiple segments (DIMS) based spectacle lens in preventing and controlling myopia in pre-myopic children aged 3 to 6 years.
Interventions
DEVICEArtificial Intelligence Assisted DIMS based Spectacle Lens
The AI-DIMS defocus spectacle frame, featuring DIMS-based lenses and an intelligent AI frame, is designed to be worn for at least 10 hours per day. The frame automatically tracks and records wearing duration parameters.
DEVICESmartwatches
Inserted prompt system of the smartwatches can remind the users to go outside. Inserted sensors can record outdoor parameters such as outdoor time, light intensity, activity pattern, etc.
Sponsors
Shanghai Eye Disease Prevention and Treatment Center
HOYA Lens Thailand LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* Age between 3 and 6 years (inclusive), regardless of gender or ethnicity. * Cycloplegic spherical equivalent refraction (SER) of the worse eye \> -0.50 D and ≤ +0.75 D, absolute cylindrical power ≤ 1.0 D, anisometropia ≤ 1.5 D. * Best corrected monocular distance high contrast VA ≥ 0.5 for ages 3-5; ≥ 0.7 for age 6. * At least one parent with SER ≤-3.00D
Exclusion criteria
* Individuals with any ocular or systemic diseases that may affect vision and refractive development (e.g., keratoconus, abnormalities in lens shape or position, Marfan syndrome, retinopathy of prematurity, etc.). * Individuals with known allergies or contraindications to cycloplegic agents. * Previous use of myopia management treatment (spectacles, atropine; CLs). * Individuals with binocular vision abnormalities: manifest strabismus, monocular suppression, abnormal fusion function, or impaired stereopsis. * Individuals unable to cooperate with examinations or communicate. * Any other conditions deemed by the investigator as unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in axial length | From baseline to the 12-month follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Cycloplegic Spherical Equivalent Refraction (SER) | From baseline to the 12-month follow-up |
| Changes in Choroidal Thickness (CT) | From baseline to the 12-month follow-up |
| Spectacle-wearing compliance and spectacle-wearing time | From baseline to the 12-month follow-up |
Countries
China
Contacts
CONTACTXiangui He, Prof
PRINCIPAL_INVESTIGATORHe, Prof
Shanghai Eye Disease Prevention and Treatment Center
Outcome results
None listed