Effect of Using Myopia Prediction Algorithm on Children's Eye Refraction in China: a Multi-center Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 1,680
- Primary Endpoint
- Incidence of SER development of at least -0.5 dioptres (D)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
Examinations of visual acuity, eye refraction and biometrics will be performed in each participating clinic by trained investigators. The investigators, outcomes assessors involved in data management and analysis will be blinded to the group assignment. The study participants, the coordinator, senior consultants, and study personnel responsible for randomisation will not be masked.
Eligibility Criteria
- Ages
- 8 Years to 9 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Myopia prediction algorithm (Other)
Not using myopia prediction algorithm
After examination of visual acuity, eye refraction and biometrics, the examination results are shown to the children.
Outcomes
Primary Outcomes
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 Outcomes
- Changes in child's average screen time per day(Up to 1 year)
- Changes in SER \and AL(Up to 1 year)
- Changes in proportion of children using spectacles(Up to 1 year)
- Changes in proportion of children using atropine(Up to 1 year)
- Changes in child's average outdoor activity time per day(Up to 1 year)
- Changes in proportion of children using orthokeratology lenses(Up to 1 year)
Investigators
Haotian Lin
Clinical Professor
Sun Yat-sen University