Myopia Control Combined PBM With Myopic Defocus Lens in Children
To study the efficacy of myopi control with two methods: low lever red light and peripheral defocus spectacles with four groups and design with prospective, double-blind, randimized, and with control for 6 month.
| Condition(s) | Myopia, Progressive |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | To study the efficacy of myopi control with two methods: low lever red light and peripheral defocus spectacles with four groups and design with prospective, double-blind, randimized, and with control for 6 month. |
| Who can participate | Inclusion Criteria: * Informed consent by the supervision of the children * 6\~13 years old (including both the 6 and 13) * SE range: -0.50\~-5.50D * Astigmatism \<=2.00D * BCVA \>=0.8 * Anisometropia \<=1.50D * Confirmed to no use of other myopia control intervention Exclusion Criteria: * Ocular lesions to effect vision or diseases (such as cataract, glaucoma, marcular pathology, cornea lesions, uveitis, retina detachment, congential opitc abnormal and etc.) * Halo, glare, toutic, ADHD, psoriasis * Systom disease: immune disease, central nerve system, Down syndrome, asthma, severe cardiopulmonary abnormal, severe liver and renal dysfunction. * Squint, ocular lesion or acute imflammation. * Other myopia control interventions within recent 3 month such as atropine, device, orthokeratology, |
| Ages | 6 Years to 13 Years |
| Sex | All |
| Lead sponsor | Beijing Airdoc Technology Co., Ltd. |
| Locations | Xuzhou, Jiangsu, China |
| Start date | 2022-12-12 |
| NCT ID | NCT05756959 |
| Official listing | https://clinicaltrials.gov/study/NCT05756959 |