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
Study ID
NCT07120737
Status
Not Yet Recruiting

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Conditions

  • High Myopia
  • Myopia

Eligibility Criteria

Sex
ALL
Age
7 Years - 14 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 13, 2025
Start date
Sep 1, 2025
Status verified
Aug 2025
Primary completion
Mar 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
224 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: the intervention group
    the intervention group wore H.A.L.T. MAX for at least 10 hours a day for 2 years.
  • No Intervention: The control group
    The control group will wear single vision lenses (SV) for at least 10 hours a day. In the first year (at 6-month follow-up), study participants in the control group with a spherical equivalent diopter change (SER) of ≥0.75 D will be switched to H.A.L.T. MAX lenses until the end of year 2. After entering year 2, all remaining control (SV) study participants will be replaced with H.A.L.T. MAX spectacles for at least 10 hours per day until the end of year 2.

Primary Outcome Measure

the proportion of change in SER of ≤ -0.75 (D) [ Time Frame: at the end of 1-year ]

Central Contacts

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