Effect of Using Myopia Prediction Algorithm
1 other identifier
interventional
1,680
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2019
CompletedFirst Posted
Study publicly available on registry
July 2, 2019
CompletedStudy Start
First participant enrolled
July 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2021
CompletedJuly 2, 2019
July 1, 2019
1.6 years
July 1, 2019
July 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Changes in SER \and AL
Up to 1 year
Changes in proportion of children using atropine
Up to 1 year
Changes in proportion of children using orthokeratology lenses
Up to 1 year
Changes in proportion of children using spectacles
Up to 1 year
Changes in child's average outdoor activity time per day
Up to 1 year
- +1 more secondary outcomes
Study Arms (2)
Using myopia prediction algorithm
EXPERIMENTALAfter 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.
Not using myopia prediction algorithm
NO INTERVENTIONAfter examination of visual acuity, eye refraction and biometrics, the examination results are shown to the children.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Children at Grade 3 (aged 8-9)
- Has the record of eye refraction examined in the past year
- Written informed consents provided
You may not qualify if:
- Definitive diagnosis of other ocular abnormalities except for refractive error
- Previous eye surgery
- Unwilling to participate in this trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
Haotian Lin
Zhongshan Ophthalmic Center, Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
July 1, 2019
First Posted
July 2, 2019
Study Start
July 8, 2019
Primary Completion
January 31, 2021
Study Completion
January 31, 2021
Last Updated
July 2, 2019
Record last verified: 2019-07