NCT07511387

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

A Pilot Study on the Short-Term Efficacy of a Novel Myopia Defocus Spectacle Lens in School-Aged Children

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 6 Years – 15 Years
• Healthy volunteers: Accepted

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.

Detailed description

Optical strategies have been shown to be effective for slowing myopia progression. The design of the BLMCL patented spectacle lens is based on existing myopic control theory of peripheral defocus spectacle lenses. This prospective, observational cohort study aims to evaluate the short-term efficacy and safety of the BLMCL lens in school-aged children. Forty participants, aged 6 to 15 years with SER between -6.00D to -0.75D and astigmatism not more than -2.00D, will be fitted with the BLMCL Lens and followed for six months. They will be required to return for five scheduled visits: baseline, delivery, 1 month, 3 months, and 6 months after lens delivery visits. The primary endpoint is the change in subfoveal choroidal thickness (SfChT) for potential effective myopia control via SfChT thickening. The secondary endpoints are the changes in AL and refraction after cycloplegia which allow comparison with other myopia control studies. Subjective symptoms will be assessed using the PREP2 and QoV questionnaires.

Conditions

• Myopia

Interventions

Type	Name	Description
OTHER	BCMC lens	BLMC spectacle lens is a spectacle lens that corrects the distance refraction and provides defocus in peripheral region

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-12-01
• Completion: 2027-03-01
• First posted: 2026-04-06
• Last updated: 2026-04-09

Locations

1 site across 1 country: Hong Kong