Investigating the Effect of Using Myopia Prediction Algorithm on Myopia Children

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

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

Study Overview

• Status: Unknown
• Conditions: Refractive Errors
• Intervention / Treatment: Other: 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

• Study Type: Interventional
• Enrollment (Anticipated): 2138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yahan Yang; Phone Number: +8615521013933; Email: yah.yang39@hotmail.com
• Study Contact Backup: Name: Haotian Lin; Phone Number: +8613802793086; Email: haot.lin@hotmail.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510623
      • Recruiting
      • Zhongshan Ophthalmic Centre
      • Contact: Yahan Yang; Phone Number: +86-15521013933

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Not using myopia prediction algorithm; After examination of visual acuity, eye refraction and biometrics, the examination results are shown to the children.
Experimental: 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 SER at 3 years.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in proportion of children using atropine	Changes in proportion of children using atropine will be calculated	Up to 1 year
Changes in proportion of children using orthokeratology lenses	Changes in proportion of children using orthokeratology lenses will be calculated	Up to 1 year
Changes in proportion of children using spectacles	Changes in proportion of children using spectacles will be calculated	Up to 1 year
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
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
Changes in SER \ and AL	Changes in SER \ and AL will be calculated; AL: axial length	Up to 1 year
Changes in SER \ and AL	Changes in SER \ and AL will be calculated; AL: axial length	Up to 2 year
Changes in proportion of children using atropine	Changes in proportion of children using atropine will be calculated	Up to 2 year
Changes in proportion of children using orthokeratology lenses	Changes in proportion of children using orthokeratology lenses will be calculated	Up to 2 year
Changes in proportion of children using spectacles	Changes in proportion of children using spectacles will be calculated	Up to 2 year
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
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
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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2019
• Primary Completion (Anticipated): November 30, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: August 2, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (Actual): August 5, 2019

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CCPMOH2019-China-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No