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In this study, the investigators aim to perform a prospective, randomized controlled study to compare the myopia development between myopia children using myopia prediction algorithm and myopia children without using myopia prediction algorithm
The investigators propose to enroll myopia children aged 8-10 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 SER at 3 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, SER, and annual progression rate. Using these predictors, the algorithm will be used to predict SER at 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of SER development of at least -1.0 dioptres (D) | SER: spherical equivalent refraction, sphere + ½ 360 cylinder; SER development of at least -1.0 dioptres: SER2 - SER1≤-0.5D; SER1: SER at baseline; SER2: SER up to 2 year | up to 2 year |
| Incidence of SER development of at least -0.5 dioptres (D) | SER: spherical equivalent refraction, 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 SER \ and AL | Changes in SER \ and AL will be calculated; AL: axial length |
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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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Centre | Recruiting | Guangzhou | Guangdong | 510623 | China |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
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The outcomes assessors involved in data management and analysis will be blinded to the group assignment. The study participants, the investigators responsible for randomization will not be masked.
| Up to 2 year |
| Changes in proportion of children using atropine | Changes in proportion of children using atropine will be calculated | Up to 1 year |
| Changes in proportion of children using atropine | Changes in proportion of children using atropine will be calculated | Up to 2 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 orthokeratology lenses | Changes in proportion of children using orthokeratology lenses will be calculated | Up to 2 year |
| Changes in proportion of children using spectacles | Changes in proportion of children using spectacles 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 2 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 outdoor activity time per day | Changes in child's average outdoor activity time per day will be calculated | Up to 2 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 |
| Changes in child's average screen time per day | Changes in child's average screen time per day will be calculated | Up to 2 year |
| D009422 |
| Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |