Investigating the Effect of Using Myopia Prediction Algorithm on Myopia Children

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
We 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

Official Title
-----------------
Investigating the Effect of Using Myopia Prediction Algorithm on Myopia Children's Eye Refraction in China: a Multi-center Randomized Control Trial

Conditions
-----------------
Refractive Errors

Intervention / Treatment
-----------------
* Other: Myopia prediction algorithm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 8-10 Has the record of eye refraction examined in the past year, SER<-0.5D Current BCVA≥0.8, SER<-0.5D, Astigmatism less than 1.50 D, anisometropia less than 1.50 D Written informed consents provided Exclusion Criteria: Definitive diagnosis of other diseases except for refractive error Previous eye surgery Previous usage of orthokeratology lenses and atropine Unwilling to participate in this trial

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Using myopia prediction algorithm<br>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. | Other: Myopia prediction algorithm<br>* Candidate predictors mainly includes age at examination, SER, and annual progression rate. Using these predictors, the algorithm will be used to predict SER at 3 years.<br>|
| No Intervention: Not using myopia prediction algorithm<br>After examination of visual acuity, eye refraction and biometrics, the examination results are shown to the children. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 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 |