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Efficacy and Safety of Spectacle Lenses With H.A.L.T. MAX Technology on High Myopia Control in Children and Adolescents
Sponsor: Shanghai Eye Disease Prevention and Treatment Center
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.
Official title: 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
Key Details
Gender
All
Age Range
7 Years - 14 Years
Study Type
INTERVENTIONAL
Enrollment
224
Start Date
2025-09-01
Completion Date
2028-12-01
Last Updated
2025-08-13
Healthy Volunteers
No
Conditions
Interventions
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
Locations (1)
Shanghai Eye Disease Prevention and Treatment Center (SEDPTC)
Shanghai, Shanghai Municipality, China