Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial

ConditionsPre-myopia Myopia

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age3-6

SponsorShanghai Eye Disease Prevention and Treatment Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Artificial Intelligence Assisted DIMS based Spectacle Lens
Device
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.
Smartwatches
Device
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.

Treatment groups

128 Participants

are divided into 2 treatment groups

Group A: Intervention groupExperimental treatment 2 interventions

Group B: Control groupOther 1 intervention