Investigating the Effect of Using Myopia Prediction Algorithm on Myopia Children
1 other identifier
interventional
2,138
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2019
CompletedStudy Start
First participant enrolled
August 3, 2019
CompletedFirst Posted
Study publicly available on registry
August 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedAugust 7, 2019
August 1, 2019
1.3 years
August 2, 2019
August 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (13)
Incidence of SER development of at least -1.0 dioptres (D)
Up to 2 year
Changes in SER \ and AL
Up to 1 year
Changes in SER \ and AL
Up to 2 year
Changes in proportion of children using atropine
Up to 1 year
Changes in proportion of children using atropine
Up to 2 year
- +8 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 SER at 3 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 mainly includes age at examination, SER, and annual progression rate. Using these predictors, the algorithm will be used to predict SER at 3 years.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongshan Ophthalmic Centre
Guangzhou, Guangdong, 510623, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
August 2, 2019
First Posted
August 5, 2019
Study Start
August 3, 2019
Primary Completion
November 30, 2020
Study Completion
November 30, 2020
Last Updated
August 7, 2019
Record last verified: 2019-08