Effect of Using Myopia Prediction Algorithm

Eye--Refractive Errors Clinical Trial

Official title:

Effect of Using Myopia Prediction Algorithm on Children's Eye Refraction in China: a Multi-center Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04005014
• Other study ID #: CCPMOH2019-China-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 8, 2019
• Est. completion date: January 31, 2021

Study information

• Verified date: July 2019
• Source: Sun Yat-sen University
• Contact: Yahan Yang
• Phone: +8615521013933
• Email: yah.yang39[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1680
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Eye--Refractive Errors
• Refractive Errors

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of SER development of at least -0.5 dioptres (D)	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	Up to 1 year
Secondary	Changes in SER \and AL	Changes in SER \and AL will be calculated; AL: axial length	Up to 1 year
Secondary	Changes in proportion of children using atropine	Changes in proportion of children using atropine will be calculated	Up to 1 year
Secondary	Changes in proportion of children using orthokeratology lenses	Changes in proportion of children using orthokeratology lenses will be calculated	Up to 1 year
Secondary	Changes in proportion of children using spectacles	Changes in proportion of children using spectacles will be calculated	Up to 1 year
Secondary	Changes in child's average outdoor activity time per day	Changes in child's average outdoor activity time per day will be calculated	Up to 1 year
Secondary	Changes in child's average screen time per day	Changes in child's average screen time per day will be calculated	Up to 1 year