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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia; High Myopia
• Intervention / Treatment: Device: H.A.L.T. MAX spectacles

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.

• Study Type: Interventional
• Enrollment (Estimated): 224
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiangui He; Phone Number: 021-62675806; Email: xianhezi@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200336
      • Shanghai Eye Disease Prevention and Treatment Center (SEDPTC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the intervention group; the intervention group wore H.A.L.T. MAX for at least 10 hours a day for 2 years.	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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at the end of 1-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at the end of 1-year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adaptation outcome	visual quality, assessed by specify questionnaire.	at the end of 1-year
Adverse events incidence	Number of participants with adverse events (e.g., headache, dizziness) attributed to lens wear.	1 year
Exploratory outcomes1	Changes in SER and AL in the SVL switch over group in the second year.	at the end of 2-year
Exploratory outcomes2	Changes in choroidal thickness from baseline in the intervention and control group by OCT.	at the end of 2-year

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center
• Collaborators: Essilor International

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: July 30, 2025
• First Submitted That Met QC Criteria: August 11, 2025
• First Posted (Actual): August 13, 2025

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: myopia; high myopia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: WS10422; IIT2024-019-AMD-01 (Other Identifier: Shanghai Eye Disease Prevention and Treatment Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No