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.
Voluntary, willing to follow the protocol, able to read and understand the information form and give free and informed consent (for parents/guardian of children subjects) and assent (for subjects aged 7-14 years old);
7-14 years old，regardless of sex;
Spherical equivalent refraction (SE) after cyclopegia ≤ -5.00 D and ≥ -9.00D;
Anisometropia and Astigmatism ≤2.50D;
Allergic or intolerant to cycloplegic drugs；
Exclude children on high dose atropine (1%) or red light therapy；
Any previous history of myopia control treatment in the previous 30 days, like low dose atropine, defocus spectacles, or thokeratology and acupuncture；
History or presence of an ocular disease, strabismus or amblyopia or other binocular vision abnormalities, accommodation dysfunction, and cataract.；
Parallel
H.A.L.T. MAX spectacles
DeviceThe Essilor® Stellest® 2.0 lens features a 2 times larger signal area, significantly enhancing the effect of slowing down myopia progression
the proportion of change in SER of ≤ -0.75 (D)
the proportion of change in SER of ≤ -0.75 (D) at the end of 1-year in both groups
The proportion of change in AL of ≥ 0.34 mm
The proportion of change in AL of ≥ 0.34 mm at the end of 1-year in both groups
Adaptation outcome
visual quality, assessed by specify questionnaire.
Adverse events incidence
Number of participants with adverse events (e.g., headache, dizziness) attributed to lens wear.
Exploratory outcomes1
Changes in SER and AL in the SVL switch over group in the second year.
Exploratory outcomes2
Changes in choroidal thickness from baseline in the intervention and control group by OCT.
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Shanghai Eye Disease Prevention and Treatment Center
Lead sponsor
Essilor International
Collaborator
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