Effect of Using Myopia Prediction Algorithm on Myopia School-aged Children's Eye Refraction in China: a Multi-center Randomized Control Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Sun Yat-sen University
- Enrollment
- 2138
- Locations
- 1
- Primary Endpoint
- Incidence of SER development of at least -0.5 dioptres (D)
- Last Updated
- 6 years ago
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
The investigators 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
Investigators
Haotian Lin
Clinical Professor
Sun Yat-sen University
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
Outcomes
Primary Outcomes
Incidence of SER development of at least -0.5 dioptres (D)
Time Frame: 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
Incidence of SER development of at least -1.0 dioptres (D)
Time Frame: 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
Secondary Outcomes
- Changes in proportion of children using orthokeratology lenses(Up to 2 year)
- Changes in child's average outdoor activity time per day(Up to 2 year)
- Changes in SER \ and AL(Up to 2 year)
- Changes in proportion of children using spectacles(Up to 2 year)
- Changes in proportion of children using atropine(Up to 2 year)
- Changes in child's average screen time per day(Up to 2 year)