NCT07120737

Efficacy and Safety of Spectacle Lenses With H.A.L.T. MAX Technology on High Myopia Control in Children and Adolescents

Efficacy and Safety of Spectacle Lenses With Maximized Highly Aspherical Lenslets Target Technology (H.A.L.T. MAX) on High Myopia Control in Children and Adolescents: a Randomized Controlled Research

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center · Academic / Other
• Sex: All
• Age: 7 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

Children aged 7-14 years with high myopia were randomly assigned to a control group or an intervention group at a 1:1 ratio. The intervention group wore H.A.L.T. MAX lenses for at least 10 hours per day for 2 years, and the control group wore ordinary single-vision (SV) spectacles for at least 10 hours per day. At the 1-year follow-up examination (6-month visit), control subjects whose equivalent spherical diopter change (SER) was ≥0.75 D were switched to H.A.L.T. MAX lenses until the end of year 2. After entering year 2, all remaining control (SV) subjects will be replaced with H.A.L.T. MAX defofocus frames for at least 10 hours per day until the end of year 2. And continue to wear it for at least 10 hours per day. To evaluate the efficacy, safety and compliance of H.A.L.T. MAX lenses in delaying myopia progression in children with high myopia, and to provide a scientific basis for the formulation and practice of public health programs for delaying myopia progression and the risk of blindness and visual impairment caused by high myopia.

Detailed description

In a 2-year randomized controlled study, the intervention group wear H.A.L.T. MAX spectacle lenses for more than 10 hours a day for 2 years. During the first year, the control group wore conventional single-vision (SV) spectacles for at least 10 hours per day. At the 6-month follow-up visit, if the spherical equivalent refraction (SER) change in the control group (SV) participants was ≥0.75 D, they were switched to H.A.L.T. MAX spectacle lenses until the end of the second year. In the second year, all remaining control group (SV) participants were transitioned to H.A.L.T. MAX defocus spectacle lenses and continued wearing them until the study concluded. To evaluate the efficacy, safety and compliance of H.A.L.T. MAX lenses for delaying myopia in children with high myopia, and to provide a scientific basis for the development of prevention strategies for children with high myopia.

Conditions

• Myopia
• High Myopia

Interventions

Type	Name	Description
DEVICE	H.A.L.T. MAX spectacles	The Essilor® Stellest® 2.0 lens features a 2 times larger signal area, significantly enhancing the effect of slowing down myopia progression

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-03-01
• Completion: 2028-12-01
• First posted: 2025-08-13
• Last updated: 2025-08-13

Locations

1 site across 1 country: China