Investigating the Effect of Using Myopia Prediction Algorithm on Myopia Children

Refractive Errors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04044755
• Other study ID #: CCPMOH2019-China-3
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: August 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 myopia children using myopia prediction algorithm and myopia children without using myopia prediction algorithm

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2138
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia
• Refractive Errors

Intervention

Other:
• Myopia prediction algorithm
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.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Centre	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of SER development of at least -0.5 dioptres (D)	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	up to 1 year
Secondary	Incidence of SER development of at least -1.0 dioptres (D)	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	Up to 2 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 SER \ and AL	Changes in SER \ and AL will be calculated; AL: axial length	Up to 2 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 atropine	Changes in proportion of children using atropine will be calculated	Up to 2 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 orthokeratology lenses	Changes in proportion of children using orthokeratology lenses will be calculated	Up to 2 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 proportion of children using spectacles	Changes in proportion of children using spectacles will be calculated	Up to 2 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 outdoor activity time per day	Changes in child's average outdoor activity time per day will be calculated	Up to 2 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
Secondary	Changes in child's average screen time per day	Changes in child's average screen time per day will be calculated	Up to 2 year