🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06860737
Active, not recruiting Not applicable

A Randomized Clinical Trial on the Effectiveness of Novel Plano Spectacle Lenses on Myopia Prevention in Pre-myopic Children

NCT06860737 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Eye Disease Prevention and Treatment Center
Phase
Not applicable
Started
2025-03-15
Last updated
2025-12-08

Condition(s) studied

Myopic Children

Investigational drug(s) / intervention(s)

Novel plano spectacle lenses

Novel 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.

Study 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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Xiangui He Shanghai China

More Shanghai Eye Disease Prevention and Treatment Center trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06860737 on ClinicalTrials.gov ↗ ← All trials in China