Effect of Using Myopia Prediction Algorithm

Overview

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.

Full Title of Study: “Effect of Using Myopia Prediction Algorithm on Children’s Eye Refraction in China: a Multi-center Randomized Control Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 31, 2021

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.

Interventions

  • Other: Myopia prediction algorithm
    • Candidate predictors included age at examination, SE, and annual progression rate. Using these predictors, the algorithm will be used to predict SE and whether patients will progress to high myopia in the subsequent 10 years.

Arms, Groups and Cohorts

  • Experimental: Using 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 SE and presence of high myopia in the subsequent 10 years.
  • No Intervention: Not using myopia prediction algorithm
    • After examination of visual acuity, eye refraction and biometrics, the examination results are shown to the children.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of SER development of at least -0.5 dioptres (D)
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 9 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Haotian Lin, Clinical Professor – Sun Yat-sen University
  • Overall Official(s)
    • Haotian Lin, Principal Investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
  • Overall Contact(s)
    • Yahan Yang, +8615521013933, yah.yang39@hotmail.com

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