Effect of Using Myopia Prediction Algorithm on Myopia School-aged Children

Sponsor

Sun Yat-sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04045951

Collaborator

(none)

2,138

Enrollment

Location

Arms

27.9

Anticipated Duration (Months)

76.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Myopia	Other: Myopia prediction algorithm	N/A

Detailed Description

The investigators 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 Design

Study Type:

Interventional

Anticipated Enrollment :

2138 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Aug 3, 2019

Anticipated Primary Completion Date :

Nov 30, 2021

Anticipated Study Completion Date :

Nov 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
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 included age at examination, SER, and annual progression rate. Using these predictors, the algorithm will be used to predict SER at 3 years.
No Intervention: Not using myopia prediction algorithm After examination of visual acuity, eye refraction and biometrics, the examination results are shown to the children.

Arm

Intervention/Treatment

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 included age at examination, SER, and annual progression rate. Using these predictors, the algorithm will be used to predict SER at 3 years.

No Intervention: Not using myopia prediction algorithm

After examination of visual acuity, eye refraction and biometrics, the examination results are shown to the children.

Outcome Measures

Primary Outcome Measures

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
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 Outcome Measures

Changes in SER \ and AL [Up to 1 year]
Changes in SER \ and AL will be calculated; AL: axial length
Changes in SER \ and AL [Up to 2 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 atropine [Up to 2 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
Changes in proportion of children using orthokeratology lenses [Up to 2 year]
Changes in proportion of children using orthokeratology lenses will be calculated
Changes in proportion of children using spectacles [Up to 1 year]
Changes in proportion of children using spectacles will be calculated
Changes in proportion of children using spectacles [Up to 2 year]
Changes in proportion of children using spectacles will be calculated
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 outdoor activity time per day [Up to 2 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 child's average screen time per day [Up to 2 year]
Changes in child's average screen time per day will be calculated

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 10 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Ophthalmic Centre	Guangzhou	Guangdong	China	510623

Sponsors and Collaborators

Sun Yat-sen University

Investigators

Principal Investigator: Haotian Lin, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Haotian Lin, Clinical Professor, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT04045951

Other Study ID Numbers:

CCPMOH2019-China-4

First Posted:

Aug 6, 2019

Last Update Posted:

Aug 7, 2019

Last Verified:

Aug 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Haotian Lin, Clinical Professor, Sun Yat-sen University

Vision Disorders

Artificial intelligence

Myopia prediction

Additional relevant MeSH terms:

Myopia

Study Results

No Results Posted as of Aug 7, 2019