Clinical trial NCT04044755: Investigating the Effect of Using Myopia Prediction Algorithm on Myopia Children
Official title: Investigating the Effect of Using Myopia Prediction Algorithm on Myopia Children's Eye Refraction in China: a Multi-center Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Refractive Errors
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 2138
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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

Primary outcomes:
measure: Incidence of SER development of at least -0.5 dioptres (D)
timeFrame: up to 1 year
Secondary outcomes:
measure: Incidence of SER development of at least -1.0 dioptres (D)
timeFrame: Up to 2 year
measure: Changes in SER \ and AL
timeFrame: Up to 1 year
measure: Changes in SER \ and AL
timeFrame: Up to 2 year
measure: Changes in proportion of children using atropine
timeFrame: Up to 1 year
measure: Changes in proportion of children using atropine
timeFrame: Up to 2 year
measure: Changes in proportion of children using orthokeratology lenses
timeFrame: Up to 1 year
measure: Changes in proportion of children using orthokeratology lenses
timeFrame: Up to 2 year
measure: Changes in proportion of children using spectacles
timeFrame: Up to 1 year
measure: Changes in proportion of children using spectacles
timeFrame: Up to 2 year
measure: Changes in child's average outdoor activity time per day
timeFrame: Up to 1 year
measure: Changes in child's average outdoor activity time per day
timeFrame: Up to 2 year
measure: Changes in child's average screen time per day
timeFrame: Up to 1 year
measure: Changes in child's average screen time per day
timeFrame: Up to 2 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Centre
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Haotian Lin
role: PRINCIPAL_INVESTIGATOR
References: