Novel myopia-defocus spectacle lens for school-aged children
A Pilot Study on the Short-Term Efficacy of a Novel Myopia Defocus Spectacle Lens in School-Aged Children
NA · The Hong Kong Polytechnic University · NCT07511387
We will test whether a new spectacle lens can slow myopia in Chinese children aged 6 to 15 by measuring eye length, refraction, and choroidal thickness over six months.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 6 Years to 15 Years |
| Sex | All |
| Sponsor | The Hong Kong Polytechnic University (other) |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT07511387 on ClinicalTrials.gov |
What this trial studies
Forty myopic children aged 6–15 with spherical equivalent between −0.75 D and −6.00 D will be fitted with the BLMCL spectacle lens and followed for six months. Participants will attend five visits (baseline, delivery, 1 month, 3 months, and 6 months) with measurements of subfoveal choroidal thickness, axial length, and cycloplegic refraction at scheduled visits. The primary endpoint is change in subfoveal choroidal thickness as a potential biomarker of myopia control; secondary endpoints are changes in axial length and refraction, and subjective symptoms recorded using PREP2 and QoV questionnaires. Safety and tolerability will be monitored throughout the study.
Who should consider this trial
Good fit: Ideal candidates are Chinese children aged 6–15 with myopia between −0.75 D and −6.00 D, astigmatism ≤ 2.00 D, anisometropia ≤ 1.50 D, good visual acuity, and no recent myopia-control treatment.
Not a fit: Children with more severe myopia outside the specified range, significant ocular pathology, prior/current amblyopia or strabismus, recent myopia-control use, or systemic conditions affecting eye growth are unlikely to benefit.
Why it matters
Potential benefit: If successful, the lens could slow eye growth in children and reduce the risk of high myopia later in life.
How similar studies have performed: Other peripheral-defocus spectacle lens approaches have shown modest slowing of myopia progression, so this lens builds on partially successful optical strategies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hong Kong
- School of Optometry, The Hong Kong Polytechnic University — Hong Kong, Hong Kong (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Myopia, Children, Myopia control, Spectacle lenses