Efficacy and Safety of Spectacle Lenses With H.A.L.T. MAX Technology on High Myopia Control in Children and Adolescents

NCT07120737 | Not Yet Recruiting DMC

• 2 other identifiers: WS10422IIT2024-019-AMD-01
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myopia; High Myopia

Keywords

myopia; high myopia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The proportion of change in AL of ≥ 0.34 mm

  at the end of 1-year

Other Outcomes (4)

• Adaptation outcome

  at the end of 1-year

• Adverse events incidence

  1 year

• Exploratory outcomes1

  at the end of 2-year

Study Arms (2)

the intervention group

EXPERIMENTAL

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 control group

NO INTERVENTION

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.

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

the intervention group

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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);
• 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.

You may not qualify if:

• 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；

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead
• Essilor International: collaborator

Study Sites (1)

Shanghai Eye Disease Prevention and Treatment Center (SEDPTC)

Shanghai, Shanghai Municipality, 200336, China

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Xiangui He

CONTACT

021-62675806; xianhezi@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In a 2-year randomized controlled study, the intervention group wore H.A.L.T. MAX for at least 10 hours a day for 2 years. 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. Only the study spectacles can be worn during the research study.

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 13, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)