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| ID | Type | Description | Link |
|---|---|---|---|
| IIT2024-019-AMD-01 | Other Identifier | Shanghai Eye Disease Prevention and Treatment Center |
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| Name | Class |
|---|---|
| Essilor International | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the intervention group | Experimental | the intervention group wore H.A.L.T. MAX for at least 10 hours a day for 2 years. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
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| 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 |
| 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 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangui He | Contact | 021-62675806 | xianhezi@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Eye Disease Prevention and Treatment Center (SEDPTC) | Shanghai | Shanghai Municipality | 200336 | China |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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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.
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| 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 |