Effect of Using Myopia Prediction Algorithm

Not Applicable

• Conditions: Eye--Refractive Errors

• Registration Number: NCT04005014
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-07-01
• Last Update Submitted: 2019-07-01
• Study First Posted: 2019-07-02
• Last Update Posted: 2019-07-02
• Study Start: 2019-07-08
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1680

Inclusion Criteria

• Children at Grade 3 (aged 8-9)
• Has the record of eye refraction examined in the past year
• Written informed consents provided

Exclusion Criteria

• Definitive diagnosis of other ocular abnormalities except for refractive error
• Previous eye surgery
• Unwilling to participate in this trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of SER development of at least -0.5 dioptres (D)	Up to 1 year	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

Secondary Outcome Measures

Name	Time	Method
Changes in proportion of children using atropine	Up to 1 year	Changes in proportion of children using atropine will be calculated
Changes in child's average outdoor activity time per day	Up to 1 year	Changes in child's average outdoor activity time per day will be calculated
Changes in proportion of children using orthokeratology lenses	Up to 1 year	Changes in proportion of children using orthokeratology lenses will be calculated
Changes in SER \and AL	Up to 1 year	Changes in SER \\and AL will be calculated; AL: axial length
Changes in proportion of children using spectacles	Up to 1 year	Changes in proportion of children using spectacles will be calculated
Changes in child's average screen time per day	Up to 1 year	Changes in child's average screen time per day will be calculated