Back to resultsEffect of Using Myopia Prediction Algorithm
Primary Purpose
Eye--Refractive Errors
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Myopia prediction algorithm
Sponsored by
About this trial
This is an interventional other trial for Eye--Refractive Errors
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Using myopia prediction algorithm
Not using myopia prediction algorithm
Arm Description
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 SE and presence of high myopia in the subsequent 10 years.
After examination of visual acuity, eye refraction and biometrics, the examination results are shown to the children.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Changes in SER \and AL
Changes in SER \and AL will be calculated; AL: axial length
Changes in proportion of children using atropine
Changes in proportion of children using atropine will be calculated
Changes in proportion of children using orthokeratology lenses
Changes in proportion of children using orthokeratology lenses will be calculated
Changes in proportion of children using spectacles
Changes in proportion of children using spectacles will be calculated
Changes in child's average outdoor activity time per day
Changes in child's average outdoor activity time per day will be calculated
Changes in child's average screen time per day
Changes in child's average screen time per day will be calculated
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04005014
Brief Title
Effect of Using Myopia Prediction Algorithm
Official Title
Effect of Using Myopia Prediction Algorithm on Children's Eye Refraction in China: a Multi-center Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 8, 2019 (Anticipated)
Primary Completion Date
January 31, 2021 (Anticipated)
Study Completion Date
January 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye--Refractive Errors
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Examinations of visual acuity, eye refraction and biometrics will be performed in each participating clinic by trained investigators. The investigators, outcomes assessors involved in data management and analysis will be blinded to the group assignment. The study participants, the coordinator, senior consultants, and study personnel responsible for randomisation will not be masked.
Allocation
Randomized
Enrollment
1680 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Using myopia prediction algorithm
Arm Type
Experimental
Arm Description
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 SE and presence of high myopia in the subsequent 10 years.
Arm Title
Not using myopia prediction algorithm
Arm Type
No Intervention
Arm Description
After examination of visual acuity, eye refraction and biometrics, the examination results are shown to the children.
Intervention Type
Other
Intervention Name(s)
Myopia prediction algorithm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of SER development of at least -0.5 dioptres (D)
Description
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
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Changes in SER \and AL
Description
Changes in SER \and AL will be calculated; AL: axial length
Time Frame
Up to 1 year
Title
Changes in proportion of children using atropine
Description
Changes in proportion of children using atropine will be calculated
Time Frame
Up to 1 year
Title
Changes in proportion of children using orthokeratology lenses
Description
Changes in proportion of children using orthokeratology lenses will be calculated
Time Frame
Up to 1 year
Title
Changes in proportion of children using spectacles
Description
Changes in proportion of children using spectacles will be calculated
Time Frame
Up to 1 year
Title
Changes in child's average outdoor activity time per day
Description
Changes in child's average outdoor activity time per day will be calculated
Time Frame
Up to 1 year
Title
Changes in child's average screen time per day
Description
Changes in child's average screen time per day will be calculated
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yahan Yang
Phone
+8615521013933
Email
yah.yang39@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Haotian Lin
Phone
+8613802793086
Email
haot.lin@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haotian Lin
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Effect of Using Myopia Prediction Algorithm
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