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In this study, the investigators aim to perform a prospective, randomized controlled study to compare the myopia development between children using myopia prediction algorithm and children without using myopia prediction algorithm.
We propose to enroll Grade 3 children from primary schools in China. Children will be given examinations of visual acuity, eye refraction and biometrics, and be assigned to two groups: participants in group A use myopia prediction algorithm to predict myopia development, while in Group B, the participants do not use myopia prediction algorithm to predict myopia development. The visual acuity, eye refraction and biometrics will be investigated over the one-year follow-up period, aiming at comparison of actual myopia development between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Using myopia prediction algorithm | Experimental | After examination of visual acuity, eye refraction and biometrics, the examination results are shown to the children. Meanwhile, myopia prediction algorithm will be used to predict SE and presence of high myopia in the subsequent 10 years. |
|
| Not using myopia prediction algorithm | No Intervention | After examination of visual acuity, eye refraction and biometrics, the examination results are shown to the children. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myopia prediction algorithm | Other | Candidate predictors included age at examination, SE, and annual progression rate. Using these predictors, the algorithm will be used to predict SE and whether patients will progress to high myopia in the subsequent 10 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of SER development of at least -0.5 dioptres (D) | SER: sphere + ½ 360 cylinder; SER development of at least -0.5 dioptres: SER2 - SER1≤-0.5D; SER1: SER at baseline; SER2: SER up to 1 year | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in SER \and AL | Changes in SER \and AL will be calculated; AL: axial length | Up to 1 year |
| Changes in proportion of children using atropine | Changes in proportion of children using atropine will be calculated |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yahan Yang | Contact | +8615521013933 | yah.yang39@hotmail.com | |
| Haotian Lin | Contact | +8613802793086 | haot.lin@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Haotian Lin | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
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Examinations of visual acuity, eye refraction and biometrics will be performed in each participating clinic by trained investigators. The investigators, outcomes assessors involved in data management and analysis will be blinded to the group assignment. The study participants, the coordinator, senior consultants, and study personnel responsible for randomisation will not be masked.
| Up to 1 year |
| Changes in proportion of children using orthokeratology lenses | Changes in proportion of children using orthokeratology lenses will be calculated | Up to 1 year |
| Changes in proportion of children using spectacles | Changes in proportion of children using spectacles will be calculated | Up to 1 year |
| Changes in child's average outdoor activity time per day | Changes in child's average outdoor activity time per day will be calculated | Up to 1 year |
| Changes in child's average screen time per day | Changes in child's average screen time per day will be calculated | Up to 1 year |