Shanghai Eye Disease Prevention and Treatment Center
Phase
Not applicable
Started
2025-09-01
Last updated
2025-08-13
Condition(s) studied
MyopiaHigh Myopia
Investigational drug(s) / intervention(s)
H.A.L.T. MAX spectacles
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
Study 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.
Eligibility
Sex
ALL
Min age
7 Years
Max age
14 Years
Healthy volunteers
No
Inclusion Criteria:
* 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;
* Best corrected distance visual acuity of at least 0.8 in both eyes;
* Willing to wear only the spectacles provided by the investigator for all days (\>10 hours) during the study without additional interventions;
* Accept randomization;
* Able to sign the informed consent form with the accompaniment and understanding of parents or guardians.
Exclusion Criteria:
* 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.；
* History of eye surgery；
* Ocular or systemic diseases that may be associated with myopia, such as Marfan syndrome, retinopathy of newborns, diabetes, etc；
* Anatomic or skin factors affecting the wearing of spectacles；
* Other conditions unsuitable for inclusion (patients with excessive expectations for the effect of the defocus spectacle lenses or desires to try other myopia interventions).
Primary outcome measure(s)
the proportion of change in SER of ≤ -0.75 (D) — at the end of 1-year the proportion of change in SER of ≤ -0.75 (D) at the end of 1-year in both groups
Trial sites (1)
Facility
City
Region
Status
Shanghai Eye Disease Prevention and Treatment Center (SEDPTC)
Shanghai
Shanghai Municipality
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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