Investigating the Effect of Using Myopia Prediction Algorithm on Myopia Children

Not Applicable

• Conditions: Refractive Errors
• Interventions: Other: Myopia prediction algorithm

• Registration Number: NCT04044755
• 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 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

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-02
• Study First Submitted QC: 2019-08-02
• Study Start: 2019-08-03
• Study First Posted: 2019-08-05
• Last Update Submitted: 2019-08-06
• Last Update Posted: 2019-08-07
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Using myopia prediction algorithm	Myopia prediction algorithm	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes in proportion of children using orthokeratology lenses	Up to 2 year	Changes in proportion of children using orthokeratology lenses will be calculated
Changes in child's average outdoor activity time per day	Up to 2 year	Changes in child's average outdoor activity time per day will be calculated
Incidence of SER development of at least -1.0 dioptres (D)	Up to 2 year	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
Changes in proportion of children using spectacles	Up to 2 year	Changes in proportion of children using spectacles will be calculated
Changes in proportion of children using atropine	Up to 2 year	Changes in proportion of children using atropine will be calculated
Changes in SER \ and AL	Up to 2 year	Changes in SER \\ and AL will be calculated; AL: axial length
Changes in child's average screen time per day	Up to 2 year	Changes in child's average screen time per day will be calculated

Trial Locations

Locations (1)

Zhongshan Ophthalmic Centre; 🇨🇳 Guangzhou, Guangdong, China