NCT07511387 Efficacy of a Novel Myopia Defocus Spectacle Lens in School-Aged Children
| NCT ID | NCT07511387 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hong Kong Polytechnic University |
| Condition | Myopia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-04-10 |
| Primary Completion | 2026-12 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
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