Investigating the Effect of Using Myopia Prediction Algorithm on Myopia Children

Sun Yat-sen University2,138 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

2,138

Conditions

Refractive Errors

Interventions

Myopia prediction algorithmOTHER

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.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Zhongshan Ophthalmic Centre

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: up to 1 year

Secondary Outcomes

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

Time frame: Up to 2 year

Changes in SER \ and AL

Changes in SER \\ and AL will be calculated; AL: axial length

Time frame: Up to 1 year

Changes in SER \ and AL

Changes in SER \\ and AL will be calculated; AL: axial length

Time frame: Up to 2 year

Changes in proportion of children using atropine

Changes in proportion of children using atropine will be calculated

Time frame: Up to 1 year

Changes in proportion of children using atropine

Changes in proportion of children using atropine will be calculated

Time frame: Up to 2 year

Changes in proportion of children using orthokeratology lenses

Changes in proportion of children using orthokeratology lenses will be calculated

Time frame: Up to 1 year

Changes in proportion of children using orthokeratology lenses

Central Contacts

Yahan Yang

CONTACT

+8615521013933 yah.yang39@hotmail.com

Haotian Lin

CONTACT

+8613802793086 haot.lin@hotmail.com

Data from ClinicalTrials.gov

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