Validation of a Predictive Algorithm to Determine the Effectiveness of Orthokeratology for Myopia Control
1 other identifier
observational
3,000
1 country
1
Brief Summary
This is a prospective study to validate a predictive algorithm for identifying fast progressing myopes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
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
February 17, 2020
CompletedFirst Posted
Study publicly available on registry
February 19, 2020
CompletedStudy Start
First participant enrolled
February 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedMarch 16, 2020
March 1, 2020
1 year
February 17, 2020
March 12, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
AUROC of the prediction algorithm for identifying fast progressing myopes
Age-specific axial length (AL) changes previously described by Wang et al.(IOVS, 52 (11), 7949-53, 2011) are used as cut-off values to determine whether a child is a fast progressor or not. A child whose AL change falls on or above the cut-off value is considered to be a fast progressor.
1 year
Secondary Outcomes (3)
Sensitivity and specificity of the prediction algorithm for identifying fast progressing myopes
1 year
Performance of an algorithm for predicting AL
1 year
Performance of an algorithm for predicting spherical equivalent refractive error
1 year
Study Arms (1)
Children with myopia
A total of 3,000 children from Zhongshan Ophthalmic Center is required to undergo ophthalmic examinations and complete questionnaires at baseline and 1yr after wearing Ortho-K.
Interventions
Eligibility Criteria
3,000 children from Zhongshan Ophthalmic Center plan to wear orthokeratology lenses for myopia control.
You may qualify if:
- D≤SER≤-0.5D
- Astigmatism≤2.0D
You may not qualify if:
- Contraindications of wearing Ortho-K.
- Diagnosis of strabismus, amblyopia and other refractive development of the eye or systemic diseases.
- Currently involved in other clinical studies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhognshan Ophthalmic Center (Zhujiang New Town Branch), Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
Related Publications (1)
Wang D, Ding X, Liu B, Zhang J, He M. Longitudinal changes of axial length and height are associated and concomitant in children. Invest Ophthalmol Vis Sci. 2011 Oct 10;52(11):7949-53. doi: 10.1167/iovs.11-7684.
PMID: 21896861BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical investigator
Study Record Dates
First Submitted
February 17, 2020
First Posted
February 19, 2020
Study Start
February 25, 2020
Primary Completion
March 1, 2021
Study Completion
August 1, 2021
Last Updated
March 16, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share