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| Name | Class |
|---|---|
| Essilor International | INDUSTRY |
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Evaluate the efficacy, safety and wearing time compliance of novel plano spectacle lenses in delaying myopia onset in pre-myopic children and provide scientific basis for the development of myopia prevention strategies for children.
Children aged 6-9 years old with pre-myopia are randomly assigned to a control group and an intervention group at a 1:1 ratio. The intervention group uses novel plano spectacle lenses for at least 8 hours a day, and the control group doesn't receive any intervention. The efficacy of novel plano spectacle lenses in delaying myopia onset in pre-myopia children is evaluated by comparing the one-year incidence of myopia onset between intervention group and control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Use of novel plano spectacle lenses for at least 8 hours a day with objective wearing time measured by smart frame and objective outdoor time measured by smart bracelet. |
|
| Control group | No Intervention | Objectively measuring outdoor time by smart bracelet. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel plano spectacle lenses | Device | Use of novel plano spectacle lenses for at least 8 hours a day with objective wearing time measured by smart frame and objective outdoor time measured by smart bracelet. |
| Measure | Description | Time Frame |
|---|---|---|
| One-year cumulative myopia incidence in either eye | One-year cumulative myopia incidence in either eye | From enrollment to the end of intervention for one year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of spherical equivalent under cycloplegia | Changes of spherical equivalent under cycloplegia | From enrollment to the end of intervention for one year |
| Changes of axial length | Changes of axial length |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) related to study intervention | Incidence and severity of adverse events (AEs) related to study intervention | From enrollment to the end of intervention for one year |
| Monocular best-corrected visual acuity (BCVA) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangui He | Shanghai | 200040 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40976937 | Derived | Wang J, Du L, Chen J, Zhang B, Yang J, Du Y, Gao W, Zou H, Xu X, He X. A randomized clinical trial on the effectiveness of plano spectacle lenses with lenslets on myopia prevention in pre-myopic children: Study protocol of a randomized controlled trial. Acta Ophthalmol. 2026 May;104(3):e329-e336. doi: 10.1111/aos.70007. Epub 2025 Sep 21. |
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Children aged 6-9 years old with pre-myopia are randomly assigned to a control group and an intervention group at a 1:1 ratio. The intervention group uses novel plano spectacle lenses for at least 8 hours a day, and the control group doesn't receive any intervention. The efficacy of novel plano spectacle lenses in delaying myopia onset in pre-myopia children is evaluated by comparing the one-year incidence of myopia onset between intervention group and control group.
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| From enrollment to the end of intervention for one year |
| Changes of choroidal thickness | Changes of choroidal thickness | From enrollment to the end of intervention for one year |
| Changes of unaided distance visual acuity | Changes of unaided distance visual acuity | From enrollment to the end of intervention for one year |
| Changes of visual acuity with novel spectacle lenses and Single Vision spectacle lenses | Changes of visual acuity with novel spectacle lenses and Single Vision spectacle lenses | From enrollment to the end of intervention for one year |
| Changes of accommodation function | Changes of accommodation function | From enrollment to the end of intervention for one year |
| Wearing time recorded in the questionnaire and smart frame | Wearing time recorded in the questionnaire and smart frame | From enrollment to the end of intervention for one year |
| Objective outdoor time recorded with smart bracelet | Objective outdoor time recorded with smart bracelet | From enrollment to the end of intervention for one year |
Monocular best-corrected visual acuity (BCVA)
| From enrollment to the end of intervention for one year |
| Assessment of symptoms, complaints related to the study intervention, as reported by participants. | Assessment of symptoms, complaints related to the study intervention, as reported by participants. | From enrollment to the end of intervention for one year |