RecruitingNot Applicable

Efficacy of a Novel Myopia Defocus Spectacle Lens in School-Aged Children

Hong Kong40 participantsStarted 2026-04-10

Plain-language summary

This study aims to evaluate the short-term efficacy and safety of a novel, proprietary spectacle lens. Forty myopic participants, aged 6 to 15 years, will be prescribed with the study spectacles for a period of six months. All subjects will be required to attend five scheduled visits. Change in subfoveal choroidal thickness (SfChT), axial length and refraction will be determined.

Who can participate

Age range6 Years – 15 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 6 to 15 years (Chinese), inclusive * Cycloplegic SER between -0.75 D and -6.00 D in both eyes * Astigmatism ≤ 2.00 D in both eyes * Anisometropia ≤ 1.50 D * BCVA of 0.04 logMAR or better in each eye Exclusion Criteria: * Previous or current use of any myopia control intervention within 6 months * Presence of any ocular pathology, amblyopia, colour vision deficiency or strabismus that could affect refractive development or visual function * History of ocular surgery or significant ocular trauma * Known systemic diseases or use of medications that could affect vision or ocular growth

What they're measuring

Change in subfoveal choroidal thickness (SfChT)

Timeframe: Delivery and 1, 3, and 6 months after delivery

Trial details

NCT IDNCT07511387

SponsorThe Hong Kong Polytechnic University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

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