MyopiaNCT07120737
Efficacy and Safety of Spectacle Lenses With H.A.L.T. MAX Technology on High Myopia Control in Children and Adolescents
A study testing H.A.L.T. MAX spectacles in people with Myopia and High Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Myopia, High Myopia
- What is being tested?
- H.A.L.T. MAX spectacles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Eye Disease Prevention and Treatment Center (SEDPTC)
Shanghai, Shanghai Municipality, 200336
About this study
Official title: 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.
Read the 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.
- Conditions
- Myopia, High Myopia
- Being tested
- H.A.L.T. MAX spectacles
- Keywords
- myopia, high myopia
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H.A.L.T. MAX spectaclesDevice
The Essilor® Stellest® 2.0 lens features a 2 times larger signal area, significantly enhancing the effect of slowing down myopia progression
| Study group | Role | What they receive |
|---|---|---|
| the intervention group | Experimental | the intervention group wore H.A.L.T. MAX for at least 10 hours a day for 2 years. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at the end of 1-year
Secondary outcomes (1)
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
Measured: at the end of 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start30 Oct 2026
- Primary completion30 Oct 2026
- Study completion30 Oct 2026
Why it stopped: Major amendment for protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Collaborators
- Essilor International
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120737
- Sponsor's protocol ID
- WS10422
- Other IDs
- IIT2024-019-AMD-01
- Status last verified
- Oct 2026
- First submitted
- 30 Jul 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07120737
- Acronym / sponsor ID
- WS10422
- Conditions
- Myopia, High Myopia
- Keywords
- myopia, high myopia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Major amendment for protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Collaborators
- Essilor International
- Study start
- 30 Oct 2026 (actual)
- Primary completion
- 30 Oct 2026 (actual)
- Study completion
- 30 Oct 2026 (actual)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| the intervention group | Experimental | Device: H.A.L.T. MAX spectaclesthe intervention group wore H.A.L.T. MAX for at least 10 hours a day for 2 years. |
| 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. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H.A.L.T. MAX spectaclesThe Essilor® Stellest® 2.0 lens features a 2 times larger signal area, significantly enhancing the effect of slowing down myopia progression | Device | the intervention group |
Primary outcome
the proportion of change in SER of ≤ -0.75 (D)
Time frame: 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
1 secondary outcome
The proportion of change in AL of ≥ 0.34 mm
Time frame: at the end of 1-year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H.A.L.T. MAX spectacles in people with Myopia and High Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of change in SER of ≤ -0.75 (D) (time frame: at the end of 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.