Refractive Errors
Conditions
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
Interventions
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.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessors involved in data management and analysis will be blinded to the group assignment. The study participants, the investigators responsible for randomization will not be masked.
Eligibility
Sex/Gender
ALL
Age
8 Years to 10 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in SER \ and AL | Up to 1 year | Changes in SER \\ and AL will be calculated; AL: axial length |
| Changes in proportion of children using atropine | Up to 1 year | Changes in proportion of children using atropine will be calculated |
| Changes in proportion of children using orthokeratology lenses | Up to 1 year | Changes in proportion of children using orthokeratology lenses 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 child's average outdoor activity time per day | 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 | Up to 1 year | Changes in child's average screen time per day will be calculated |
| Changes in proportion of children using spectacles | Up to 1 year | Changes in proportion of children using spectacles will be calculated |
Countries
China
Contacts
Primary ContactYahan Yang
Backup ContactHaotian Lin
Outcome results
None listed